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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01301625

Registration number

NCT01301625

Ethics application status

Date submitted

4/02/2011

Date registered

23/02/2011

Date last updated

7/11/2018

Titles & IDs

Public title

MitraClip System in Australia and New Zealand

Scientific title

A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand

Secondary ID [1]

Protocol #M10-001

Universal Trial Number (UTN)

Trial acronym

MitraClipANZ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mitral Regurgitation

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Treatment: Devices - MitraClip Implant

MitraClip Implant - Eligible patients undergoing a MitraClip procedure in Australia and New Zealand

Treatment: Devices: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

Timepoint [1]

Baseline

Primary outcome [2]

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

Timepoint [2]

30 days

Primary outcome [3]

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

Timepoint [3]

6 months

Primary outcome [4]

Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)

Timepoint [4]

12 months

Secondary outcome [1]

Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted

Timepoint [1]

Day 0 (On the day of procedure)

Secondary outcome [2]

Number of Participants With Acute Procedural Success Rate

Timepoint [2]

At day 0 (on the day of index procedure)

Secondary outcome [3]

Procedure Time

Timepoint [3]

At day 0 (on the day of index procedure)

Secondary outcome [4]

Device Time

Timepoint [4]

At day 0 (on the day of index procedure)

Secondary outcome [5]

Fluoroscopy Duration

Timepoint [5]

At day 0 (on the day of index procedure)

Secondary outcome [6]

Total Contrast Volume

Timepoint [6]

At day 0 (on the day of index procedure)

Secondary outcome [7]

Left Ventricle End Diastolic Volume (LVEDV)

Timepoint [7]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [8]

Left Ventricle End Diastolic Volume (LVEDV)

Timepoint [8]

At Baseline and 30 Days

Secondary outcome [9]

Left Ventricle End Diastolic Volume (LVEDV)

Timepoint [9]

At Baseline and 12 months

Secondary outcome [10]

Left Ventricular End Systolic Volume (LVESV)

Timepoint [10]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [11]

Left Ventricular End Systolic Volume (LVESV)

Timepoint [11]

At Baseline and 30 Days

Secondary outcome [12]

Left Ventricular End Systolic Volume (LVESV)

Timepoint [12]

At Baseline and 12 months

Secondary outcome [13]

Left Ventricular Ejection Fraction (LVEF)

Timepoint [13]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [14]

Left Ventricular Ejection Fraction (LVEF)

Timepoint [14]

At Baseline and 30 Days

Secondary outcome [15]

Left Ventricular Ejection Fraction (LVEF)

Timepoint [15]

At Baseline and 12 months

Secondary outcome [16]

Number of Participants With MR Severity

Timepoint [16]

Baseline

Secondary outcome [17]

Number of Participants With MR Severity

Timepoint [17]

At discharge (=7 days of index procedure)

Secondary outcome [18]

Number of Participants With MR Severity

Timepoint [18]

30 days

Secondary outcome [19]

Number of Participants With MR Severity

Timepoint [19]

6 months

Secondary outcome [20]

Number of Participants With MR Severity

Timepoint [20]

12 months

Secondary outcome [21]

Left Ventricular Internal Diameter End Diastole (LVIDd)

Timepoint [21]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [22]

Left Ventricular Internal Diameter End Diastole (LVIDd)

Timepoint [22]

At Baseline and 30 Days

Secondary outcome [23]

Left Ventricular Internal Diameter End Diastole (LVIDd)

Timepoint [23]

At Baseline and 12 Months

Secondary outcome [24]

Left Ventricular Internal Diameter End Systole (LVIDs)

Timepoint [24]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [25]

Left Ventricular Internal Diameter End Systole (LVIDs)

Timepoint [25]

At Baseline and 30 Days

Secondary outcome [26]

Left Ventricular Internal Diameter End Systole (LVIDs)

Timepoint [26]

At Baseline and 12 Months

Secondary outcome [27]

Regurgitant Volume

Timepoint [27]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [28]

Regurgitant Volume

Timepoint [28]

At Baseline and 30 Days

Secondary outcome [29]

Regurgitant Volume

Timepoint [29]

At Baseline and 12 Months

Secondary outcome [30]

Regurgitant Fraction

Timepoint [30]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [31]

Regurgitant Fraction

Timepoint [31]

At Baseline and 30 Days

Secondary outcome [32]

Regurgitant Fraction

Timepoint [32]

At Baseline and 12 Months

Secondary outcome [33]

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

Timepoint [33]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [34]

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

Timepoint [34]

At Baseline and 30 Days

Secondary outcome [35]

Mitral Valve Area (MVA) by Pressure Half-time (PHT)

Timepoint [35]

At Baseline and 12 Months

Secondary outcome [36]

Mitral Valve Mean Gradient

Timepoint [36]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [37]

Mitral Valve Mean Gradient

Timepoint [37]

At Baseline and 30 Days

Secondary outcome [38]

Mitral Valve Mean Gradient

Timepoint [38]

At Baseline and 12 Months

Secondary outcome [39]

Left Atrial Volume

Timepoint [39]

At Baseline and Discharge (=7 days of index procedure)

Secondary outcome [40]

Left Atrial Volume

Timepoint [40]

At Baseline and 30 Days

Secondary outcome [41]

Left Atrial Volume

Timepoint [41]

At Baseline and 12 Months

Secondary outcome [42]

Six Minute Walking Distance

Timepoint [42]

Baseline

Secondary outcome [43]

Six Minute Walking Distance

Timepoint [43]

30 days

Secondary outcome [44]

Six Minute Walking Distance

Timepoint [44]

6 months

Secondary outcome [45]

Six Minute Walking Distance

Timepoint [45]

12 months

Secondary outcome [46]

Percentage of Participants With New York Heart Association (NYHA) Class

Timepoint [46]

Baseline

Secondary outcome [47]

Percentage of Participants With New York Heart Association (NYHA) Class

Timepoint [47]

30 days

Secondary outcome [48]

Percentage of Participants With New York Heart Association (NYHA) Class

Timepoint [48]

6 months

Secondary outcome [49]

Percentage of Participants With New York Heart Association (NYHA) Class

Timepoint [49]

12 months

Secondary outcome [50]

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days

Timepoint [50]

30 days

Secondary outcome [51]

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months

Timepoint [51]

6 months

Secondary outcome [52]

Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months

Timepoint [52]

12 months

Secondary outcome [53]

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

Timepoint [53]

Baseline

Secondary outcome [54]

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

Timepoint [54]

30 days

Secondary outcome [55]

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

Timepoint [55]

6 months

Secondary outcome [56]

Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)

Timepoint [56]

12 months

Secondary outcome [57]

Number of Participants With Mitral Valve Surgery

Timepoint [57]

30 days of Post-MitraClip Procedure

Secondary outcome [58]

Number of Participants With Second Intervention to Place an Additional MitraClip Device

Timepoint [58]

Through 12 months

Secondary outcome [59]

Rate of Patients Rehospitalized

Timepoint [59]

30 days

Secondary outcome [60]

Duration of Rehospitalization

Timepoint [60]

30 days

Secondary outcome [61]

Number of Participants at Discharge Facility

Timepoint [61]

< or = 12 days

Secondary outcome [62]

Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration

Timepoint [62]

Post index procedure within 30 days

Secondary outcome [63]

Post-procedure Hospital Stay

Timepoint [63]

Post index procedure within 30 days

Eligibility

Key inclusion criteria

* Age 18 years or older.
* MR = 3+ .
* Transseptal catheterization and femoral vein access feasible.
* Placement of the MitraClip device on mitral leaflets feasible.
* Mitral valve orifice area = 4.0 cm2.
* Written informed consent obtained.
* The patient agrees to return for follow-up visits.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Need for emergency surgery, other cardiac surgery.
* Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
* Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
* Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
* Transesophageal echocardiography (TEE) contraindicated.
* Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
* Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
* Pregnant or planning pregnancy within next 12 months.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/11/2011

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/09/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,WA

Recruitment hospital [1]

St. Vincent's Hospital Sydney - Darlinghurst

Recruitment hospital [2]

Macquarie University Hosptial - North Ryde

Recruitment hospital [3]

North Shore Private Hospital - St Leonards

Recruitment hospital [4]

The Prince Charles Hospital - Chermside

Recruitment hospital [5]

Flinders Medical Centre - Bedford Park

Recruitment hospital [6]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

2010 - Darlinghurst

Recruitment postcode(s) [2]

2109 - North Ryde

Recruitment postcode(s) [3]

2065 - St Leonards

Recruitment postcode(s) [4]

4032 - Chermside

Recruitment postcode(s) [5]

5042 - Bedford Park

Recruitment postcode(s) [6]

6009 - Nedlands

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Abbott Medical Devices

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Abbott

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.

Trial website

https://clinicaltrials.gov/study/NCT01301625

Trial related presentations / publications

Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.
Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.
Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8. doi: 10.1002/ccd.20917.
Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4. Erratum In: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].
Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21.
Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.
Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
Nor Aripin KN, Sammons HM, Choonara I. Published pediatric randomized drug trials in developing countries, 1996-2002. Paediatr Drugs. 2010 Apr 1;12(2):99-103. doi: 10.2165/11316260-000000000-00000.
Auricchio A, Schillinger W, Meyer S, Maisano F, Hoffmann R, Ussia GP, Pedrazzini GB, van der Heyden J, Fratini S, Klersy C, Komtebedde J, Franzen O; PERMIT-CARE Investigators. Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling. J Am Coll Cardiol. 2011 Nov 15;58(21):2183-9. doi: 10.1016/j.jacc.2011.06.061.
Conradi L, Treede H, Franzen O, Seiffert M, Baldus S, Schirmer J, Meinertz T, Reichenspurner H. Impact of MitraClip therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg. 2011 Dec;40(6):1521-6. doi: 10.1016/j.ejcts.2011.03.007. Epub 2011 Apr 15.
Divchev D, Kische S, Paranskaya L, Schneider H, Rehders T, Ortak J, Akin I, Turan G, Turan CH, Steinhoff G, Noldge-Schomburg G, Nienaber CA, Ince H. In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip(R) device. J Interv Cardiol. 2012 Apr;25(2):180-9. doi: 10.1111/j.1540-8183.2011.00688.x. Epub 2011 Dec 21.
Franzen O, van der Heyden J, Baldus S, Schluter M, Schillinger W, Butter C, Hoffmann R, Corti R, Pedrazzini G, Swaans MJ, Neuss M, Rudolph V, Surder D, Grunenfelder J, Eulenburg C, Reichenspurner H, Meinertz T, Auricchio A. MitraClip(R) therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011 May;13(5):569-76. doi: 10.1093/eurjhf/hfr029. Epub 2011 Apr 6.
Gaemperli O, Moccetti M, Surder D, Biaggi P, Hurlimann D, Kretschmar O, Buehler I, Bettex D, Felix C, Luscher TF, Falk V, Grunenfelder J, Corti R. Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes. Heart. 2012 Jan;98(2):126-32. doi: 10.1136/heartjnl-2011-300705. Epub 2011 Oct 7.
Pleger ST, Mereles D, Schulz-Schonhagen M, Krumsdorf U, Chorianopoulos E, Rottbauer W, Katus HA, Bekeredjian R. Acute safety and 30-day outcome after percutaneous edge-to-edge repair of mitral regurgitation in very high-risk patients. Am J Cardiol. 2011 Nov 15;108(10):1478-82. doi: 10.1016/j.amjcard.2011.06.069. Epub 2011 Sep 3.
Rudolph V, Knap M, Franzen O, Schluter M, de Vries T, Conradi L, Schirmer J, Treede H, Wegscheider K, Costard-Jackle A, Meinertz T, Reichenspurner H, Baldus S. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol. 2011 Nov 15;58(21):2190-5. doi: 10.1016/j.jacc.2011.07.047.
Schillinger W, Athanasiou T, Weicken N, Berg L, Tichelbacker T, Puls M, Hunlich M, Wachter R, Helms HJ, Seipelt R, Schondube FA, Hasenfuss G. Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients. Eur J Heart Fail. 2011 Dec;13(12):1331-9. doi: 10.1093/eurjhf/hfr141. Epub 2011 Oct 24. Erratum In: Eur J Heart Fail. 2012 Jun;14(6):679.
Treede H, Schirmer J, Rudolph V, Franzen O, Knap M, Schluter M, Conradi L, Seiffert M, Koschyk D, Meinertz T, Baldus S, Reichenspurner H. A heart team's perspective on interventional mitral valve repair: percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients. J Thorac Cardiovasc Surg. 2012 Jan;143(1):78-84. doi: 10.1016/j.jtcvs.2011.09.033. Epub 2011 Oct 27.
Ussia GP, Cammalleri V, Sarkar K, Scandura S, Imme S, Pistritto AM, Caggegi A, Chiaranda M, Mangiafico S, Barbanti M, Scarabelli M, Mule M, Aruta P, Tamburino C. Quality of life following percutaneous mitral valve repair with the MitraClip System. Int J Cardiol. 2012 Mar 8;155(2):194-200. doi: 10.1016/j.ijcard.2011.08.853. Epub 2011 Sep 28.
Chan PH, Di Mario C, Franzen O. Dissociation between anatomical and functional results after MitraClip implantation. Int J Cardiol. 2012 Mar 8;155(2):175-6. doi: 10.1016/j.ijcard.2011.10.047. Epub 2011 Nov 9. No abstract available.
Rogers JH, Bolling SF. Editorial comment: Surgery after MitraClip therapy: you can't win them all. Eur J Cardiothorac Surg. 2011 Dec;40(6):1526-8. doi: 10.1016/j.ejcts.2011.04.024. Epub 2011 Jun 12. No abstract available.
Turi ZG, Rosenbloom M. An option for the high-comorbidity patient with mitral regurgitation. J Am Coll Cardiol. 2012 Jan 10;59(2):140-2. doi: 10.1016/j.jacc.2011.09.049. No abstract available.
Altiok E, Becker M, Hamada S, Reith S, Marx N, Hoffmann R. Optimized guidance of percutaneous edge-to edge repair of the mitral valve using real-time 3-D transesophageal echocardiography. Clin Res Cardiol. 2011 Aug;100(8):675-81. doi: 10.1007/s00392-011-0296-1. Epub 2011 Mar 3.
Bergsland J, Mujanovic E, Elle OJ, Mirtaheri P, Fosse E. Minimally invasive repair of the mitral valve: technological and clinical developments. Minim Invasive Ther Allied Technol. 2011 Apr;20(2):72-7. doi: 10.3109/13645706.2011.554843.
Biner S, Perk G, Kar S, Rafique AM, Slater J, Shiota T, Hussaini A, Chou S, Kronzon I, Siegel RJ. Utility of combined two-dimensional and three-dimensional transesophageal imaging for catheter-based mitral valve clip repair of mitral regurgitation. J Am Soc Echocardiogr. 2011 Jun;24(6):611-7. doi: 10.1016/j.echo.2011.02.005. Epub 2011 Mar 23.
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Public notes

Contacts

Principal investigator

Name

David Muller, MD

Address

St Vincent's Hospital - Sydney, Australia

Country

Phone

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Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

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No Supporting Document Provided

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Results are available at https://clinicaltrials.gov/study/NCT01301625

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