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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02592369

Registration number

NCT02592369

Ethics application status

Date submitted

20/10/2015

Date registered

30/10/2015

Titles & IDs

Public title

CoreValve™ Evolut R™ FORWARD Study

Scientific title

The Medtronic CoreValve™ Evolut R™ FORWARD Study

Secondary ID [1]

Evolut R™ FORWARD Study

Universal Trial Number (UTN)

Trial acronym

FORWARD

Linked study record

Health condition

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

Aortic Valve Stenosis

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Treatment: Devices - Medtronic CoreValve™ Evolut R™ System

Treatment: Devices: Medtronic CoreValve™ Evolut R™ System
The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

All-cause mortality rate

Timepoint [1]

30 days post implant

Secondary outcome [1]

Device success according to VARC2

Timepoint [1]

24h to 7 days post implant

Secondary outcome [2]

Hemodynamic performance

Timepoint [2]

24h to 7 days and 1 year post implant

Secondary outcome [3]

Hemodynamic performance

Timepoint [3]

24h to 7 days and 1 year post implant

Secondary outcome [4]

Hemodynamic performance

Timepoint [4]

24h to 7 days and 1 year post implant

Secondary outcome [5]

Early safety composite endpoint according to VARC2

Timepoint [5]

30 days post implant

Secondary outcome [6]

Event rates according to VARC2

Timepoint [6]

30 days post implant

Secondary outcome [7]

Rate of new permanent pacemaker implant

Timepoint [7]

30 days post implant

Eligibility

Key inclusion criteria

* Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
* Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context
* Age =80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

* Society of Thoracic Surgeons (STS) predicted risk of mortality =8% OR
* Documented heart team agreement of risk for AVR due to frailty or comorbidities.
* Geographically stable and willing to return to the implanting site for all follow-up visits
* Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial
* The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
* Preexisting mechanical heart valve in aortic position
* Ongoing sepsis, including active endocarditis
* Anatomically not suitable for the Evolut R system
* Estimated life expectancy of less than 1 year
* Participating in another trial that may influence the outcome of this trial
* Need for emergency surgery for any reason

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

6/02/2020

Sample size

Target

Accrual to date

Final

1060

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Adelaide

Recruitment hospital [2]

Monash Medical Centre - Melbourne

Recruitment hospital [3]

The Alfred Hospital - Melbourne

Recruitment hospital [4]

Fiona Stanley Hospital Perth - Perth

Recruitment postcode(s) [1]

- Adelaide

Recruitment postcode(s) [2]

- Melbourne

Recruitment postcode(s) [3]

- Perth

Recruitment outside Australia

Country [1]

Belgium

State/province [1]

Antwerpen

Country [2]

Canada

State/province [2]

London

Country [3]

Canada

State/province [3]

Toronto

Country [4]

Canada

State/province [4]

Vancouver

Country [5]

Colombia

State/province [5]

Cali

Country [6]

Czechia

State/province [6]

Trinec

Country [7]

France

State/province [7]

Creteil

Country [8]

France

State/province [8]

Lille

Country [9]

France

State/province [9]

Massy

Country [10]

France

State/province [10]

Paris

Country [11]

France

State/province [11]

Toulouse

Country [12]

Germany

State/province [12]

Bad Oeynhausen

Country [13]

Germany

State/province [13]

Berlin

Country [14]

Germany

State/province [14]

Bonn

Country [15]

Germany

State/province [15]

Cottbus

Country [16]

Germany

State/province [16]

Dresden

Country [17]

Germany

State/province [17]

Duesseldorf

Country [18]

Germany

State/province [18]

Essen

Country [19]

Germany

State/province [19]

Frankfurt

Country [20]

Germany

State/province [20]

Hamburg

Country [21]

Germany

State/province [21]

Karlsruhe

Country [22]

Germany

State/province [22]

Leipzig

Country [23]

Germany

State/province [23]

Munich

Country [24]

Greece

State/province [24]

Athens

Country [25]

Hungary

State/province [25]

Budapest

Country [26]

Israel

State/province [26]

Tel-Aviv

Country [27]

Italy

State/province [27]

Brescia

Country [28]

Italy

State/province [28]

Catania

Country [29]

Italy

State/province [29]

Milan

Country [30]

Italy

State/province [30]

Pisa

Country [31]

Netherlands

State/province [31]

Amsterdam

Country [32]

Netherlands

State/province [32]

Eindhoven

Country [33]

Netherlands

State/province [33]

Nieuwegein

Country [34]

Netherlands

State/province [34]

Rotterdam

Country [35]

Norway

State/province [35]

Oslo

Country [36]

Panama

State/province [36]

Panama

Country [37]

Poland

State/province [37]

Warsaw

Country [38]

Portugal

State/province [38]

Vila Nova de Gaia

Country [39]

Saudi Arabia

State/province [39]

Riyadh

Country [40]

South Africa

State/province [40]

Cape Town

Country [41]

Spain

State/province [41]

Malaga

Country [42]

Spain

State/province [42]

Oviedo

Country [43]

Spain

State/province [43]

Santiago de Compostela

Country [44]

Sweden

State/province [44]

Uppsala

Country [45]

United Kingdom

State/province [45]

Belfast

Country [46]

United Kingdom

State/province [46]

Brighton

Country [47]

United Kingdom

State/province [47]

Leeds

Country [48]

United Kingdom

State/province [48]

Wolverhampton

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Medtronic Cardiovascular

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Trial website

https://clinicaltrials.gov/study/NCT02592369

Trial related presentations / publications

Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.
Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.
Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas M, Schachinger V, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, Romano M, Serruys P, Wimmer-Greinecker G; PARTNER EU Investigator Group. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011 Jan;32(2):148-57. doi: 10.1093/eurheartj/ehq427. Epub 2010 Nov 12.
Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
Genereux P, Head SJ, Wood DA, Kodali SK, Williams MR, Paradis JM, Spaziano M, Kappetein AP, Webb JG, Cribier A, Leon MB. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications. Eur Heart J. 2012 Oct;33(19):2388-98. doi: 10.1093/eurheartj/ehs220. Epub 2012 Jul 31.
Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kovac J, Serruys PW, Labinaz M, den Heijer P, Mullen M, Tymchak W, Windecker S, Mueller R, Grube E. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol. 2011 Apr 19;57(16):1650-7. doi: 10.1016/j.jacc.2010.11.044.
Ussia GP, Barbanti M, Petronio AS, Tarantini G, Ettori F, Colombo A, Violini R, Ramondo A, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, De Carlo M, Napodano M, Fiorina C, De Marco F, Antoniucci D, de Cillis E, Capodanno D, Tamburino C; CoreValve Italian Registry Investigators. Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J. 2012 Apr;33(8):969-76. doi: 10.1093/eurheartj/ehr491. Epub 2012 Jan 12.
Walther T, Dewey T, Borger MA, Kempfert J, Linke A, Becht R, Falk V, Schuler G, Mohr FW, Mack M. Transapical aortic valve implantation: step by step. Ann Thorac Surg. 2009 Jan;87(1):276-83. doi: 10.1016/j.athoracsur.2008.08.017.
Walther T, Mollmann H, van Linden A, Kempfert J. Transcatheter aortic valve implantation transapical: step by step. Semin Thorac Cardiovasc Surg. 2011 Spring;23(1):55-61. doi: 10.1053/j.semtcvs.2011.05.006.
Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hutter A, Tassani-Prell P, Laborde JC, Bauernschmitt R. Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients. Eur J Cardiothorac Surg. 2011 Nov;40(5):1105-13. doi: 10.1016/j.ejcts.2011.03.022. Epub 2011 Apr 22.
Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR; PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. doi: 10.1016/j.jtcvs.2012.01.055.
Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012 May 15;8(1):129-38. doi: 10.4244/EIJV8I1A20.
Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, van der Boon RM, van Geuns RJ, van der Lugt A, Serruys PW, Rodes-Cabau J, van Domburg RT, Koudstaal PJ, de Jaegere PP. Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 1;109(11):1637-43. doi: 10.1016/j.amjcard.2012.01.389. Epub 2012 Mar 15.
Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, Muller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012 Mar 27;59(13):1134-41. doi: 10.1016/j.jacc.2011.11.048.
Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
Tchetche D, Dumonteil N, Sauguet A, Descoutures F, Luz A, Garcia O, Soula P, Gabiache Y, Fournial G, Marcheix B, Carrie D, Fajadet J. Thirty-day outcome and vascular complications after transarterial aortic valve implantation using both Edwards Sapien and Medtronic CoreValve bioprostheses in a mixed population. EuroIntervention. 2010 Jan;5(6):659-65. doi: 10.4244/eijv5i6a109.
Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Ligthart J, Schultz C, de Jaegere PP, Serruys PW. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience. EuroIntervention. 2010 Jan;5(6):673-9. doi: 10.4244/eijv5i6a111.
Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Garcia-Garcia H, Schultz C, van Domburg R, van Es GA, van Geuns R, de Jaegere P, Serruys PW. Persistent conduction abnormalities and requirements for pacemaking six months after transcatheter aortic valve implantation. EuroIntervention. 2010 Sep;6(4):475-84. doi: 10.4244/EIJ30V6I4A80.
Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leoni L, Razzolini R, Corrado D, Bonato R, Basso C, Thiene G, Gerosa G, Isabella G, Iliceto S, Napodano M. Incidence, predictors, and outcome of conduction disorders after transcatheter self-expandable aortic valve implantation. Am J Cardiol. 2011 Mar 1;107(5):747-54. doi: 10.1016/j.amjcard.2010.10.054. Epub 2011 Jan 19.
van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens L, Rodes-Cabau J, van Domburg RT, Serruys PW, Anderson RH, de Jaegere PP. New conduction abnormalities after TAVI--frequency and causes. Nat Rev Cardiol. 2012 May 1;9(8):454-63. doi: 10.1038/nrcardio.2012.58.
Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-Chico JL, Nuis RJ, Kauer F, Schultz C, Serruys PW, de Jaegere PP, Geleijnse ML. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction. Am J Cardiol. 2011 Jan 15;107(2):285-9. doi: 10.1016/j.amjcard.2010.09.015. Epub 2010 Dec 2.
Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Richardt D, Tolg R, Richardt G. Anatomic and procedural predictors of paravalvular aortic regurgitation after implantation of the Medtronic CoreValve bioprosthesis. J Am Coll Cardiol. 2010 Nov 9;56(20):1623-9. doi: 10.1016/j.jacc.2010.06.035.
Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorfano M, Maisano F, Godino C, Chieffo A, Alfieri O, Colombo A. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):432-43. doi: 10.1002/ccd.23003. Epub 2011 Jul 25.
Manoharan G, Van Mieghem NM, Windecker S, Bosmans J, Bleiziffer S, Modine T, Linke A, Scholtz W, Chevalier B, Gooley R, Zeng C, Oh JK, Grube E. 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2326-2334. doi: 10.1016/j.jcin.2018.07.032.
Grube E, Van Mieghem NM, Bleiziffer S, Modine T, Bosmans J, Manoharan G, Linke A, Scholtz W, Tchetche D, Finkelstein A, Trillo R, Fiorina C, Walton A, Malkin CJ, Oh JK, Qiao H, Windecker S; FORWARD Study Investigators. Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study. J Am Coll Cardiol. 2017 Aug 15;70(7):845-853. doi: 10.1016/j.jacc.2017.06.045.

Public notes

Contacts

Principal investigator

Name

Eberhard Grube, Prof. Dr.

Address

University Hospital, Bonn

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/69/NCT02592369/Prot_000.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/69/NCT02592369/SAP_001.pdf
Informed consent form	Informed Consent Form: Informed Consent Form	https://cdn.clinicaltrials.gov/large-docs/69/NCT02592369/ICF_002.pdf
Informed consent form	Informed Consent Form: Data Release Form	https://cdn.clinicaltrials.gov/large-docs/69/NCT02592369/ICF_003.pdf

Results publications and other study-related documents

Type	Citations or Other Details
Journal	Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, ... [More Details]
Journal	Thomas M, Schymik G, Walther T, Himbert D, Lefevre... [More Details]
Journal	Lefevre T, Kappetein AP, Wolner E, Nataf P, Thomas... [More Details]
Journal	Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Sv... [More Details]
Journal	Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, S... [More Details]
Journal	Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleima... [More Details]
Journal	Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Cosell... [More Details]
Journal	Webb JG, Wood DA. Current status of transcatheter ... [More Details]
Journal	Genereux P, Head SJ, Wood DA, Kodali SK, Williams ... [More Details]
Journal	Buellesfeld L, Gerckens U, Schuler G, Bonan R, Kov... [More Details]
Journal	Ussia GP, Barbanti M, Petronio AS, Tarantini G, Et... [More Details]
Journal	Walther T, Dewey T, Borger MA, Kempfert J, Linke A... [More Details]
Journal	Walther T, Mollmann H, van Linden A, Kempfert J. T... [More Details]
Journal	Lange R, Bleiziffer S, Piazza N, Mazzitelli D, Hut... [More Details]
Journal	Miller DC, Blackstone EH, Mack MJ, Svensson LG, Ko... [More Details]
Journal	Eggebrecht H, Schmermund A, Voigtlander T, Kahlert... [More Details]
Journal	Nuis RJ, Van Mieghem NM, Schultz CJ, Moelker A, va... [More Details]
Journal	Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adena... [More Details]
Journal	Kodali SK, Williams MR, Smith CR, Svensson LG, Web... [More Details]
Journal	Tchetche D, Dumonteil N, Sauguet A, Descoutures F,... [More Details]
Journal	Van Mieghem NM, Nuis RJ, Piazza N, Apostolos T, Li... [More Details]
Journal	Piazza N, Nuis RJ, Tzikas A, Otten A, Onuma Y, Gar... [More Details]
Journal	Fraccaro C, Buja G, Tarantini G, Gasparetto V, Leo... [More Details]
Journal	van der Boon RM, Nuis RJ, Van Mieghem NM, Jordaens... [More Details]
Journal	Tzikas A, van Dalen BM, Van Mieghem NM, Gutierrez-... [More Details]
Journal	Sherif MA, Abdel-Wahab M, Stocker B, Geist V, Rich... [More Details]
Journal	Takagi K, Latib A, Al-Lamee R, Mussardo M, Montorf... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT02592369

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