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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03499236




Registration number
NCT03499236
Ethics application status
Date submitted
29/03/2018
Date registered
17/04/2018

Titles & IDs
Public title
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Scientific title
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Secondary ID [1] 0 0
CL7018
Universal Trial Number (UTN)
Trial acronym
RELIEVE-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - V-Wave Interatrial Shunt
Other interventions - Control

Experimental: Treatment - Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation

Other: Control - Control arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility, but will not have transseptal catheterization or shunt implantation.

Experimental: Roll in - Roll in arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation


Treatment: Devices: V-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.

Other interventions: Control
Right heart catheterization, invasive echocardiography.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Timepoint [1] 0 0
30-days after randomization
Primary outcome [2] 0 0
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [2] 0 0
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary outcome [1] 0 0
6MWT changes
Timepoint [1] 0 0
Baseline to 12 months
Secondary outcome [2] 0 0
KCCQ changes
Timepoint [2] 0 0
Baseline to 12 months
Secondary outcome [3] 0 0
KCCQ changes
Timepoint [3] 0 0
Baseline through study completion, maximum of five years
Secondary outcome [4] 0 0
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Timepoint [4] 0 0
Baseline through study completion, maximum of five years
Secondary outcome [5] 0 0
Time to all-cause death or first heart failure hospitalization
Timepoint [5] 0 0
Baseline through study completion, maximum of five years
Secondary outcome [6] 0 0
Cumulative heart failure hospitalizations
Timepoint [6] 0 0
Baseline through study completion, maximum of five years
Secondary outcome [7] 0 0
Time to first heart failure hospitalization
Timepoint [7] 0 0
Baseline through study completion, maximum of five years
Secondary outcome [8] 0 0
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Timepoint [8] 0 0
Baseline through study completion, maximum of five years

Eligibility
Key inclusion criteria
Main

* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications

Main
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Systolic blood pressure <90 or >160 mmHg
* Presence of Intracardiac thrombus
* Pulmonary hypertension with PASP of =70 mm/Hg or PVR > 4 WU
* Significant RV dysfunction - TAPSE <12mm or RVFAC =25%
* Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
* Moderate to severe aortic or mitral stenosis
* Stroke or TIA or DVT within the last 6 months
* eGFR <25 ml/min/1.73 m^2
* Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
* Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
* Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
Accrual to date
Final
605
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [5] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Minnesota
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
State/province [18] 0 0
Utah
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United States of America
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Virginia
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Belgium
State/province [20] 0 0
Antwerp
Country [21] 0 0
Belgium
State/province [21] 0 0
Brugge
Country [22] 0 0
Canada
State/province [22] 0 0
Montréal
Country [23] 0 0
Canada
State/province [23] 0 0
Québec
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
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Germany
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Leipzig
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Germany
State/province [27] 0 0
Mainz
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Germany
State/province [28] 0 0
München
Country [29] 0 0
Germany
State/province [29] 0 0
Remscheid
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Germany
State/province [30] 0 0
Rostock
Country [31] 0 0
Israel
State/province [31] 0 0
Ashdod
Country [32] 0 0
Israel
State/province [32] 0 0
Be'er Ya'aqov
Country [33] 0 0
Israel
State/province [33] 0 0
Beer-Sheva
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Rechovot
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Israel
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Tel Aviv
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Israel
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Tiberias
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Netherlands
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Utrecht
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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New Zealand
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Grafton
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Poland
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Katowice
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Poland
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Warszawa
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Valencia
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Spain
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Valladolid
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Switzerland
State/province [53] 0 0
Bern
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Switzerland
State/province [54] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
V-Wave Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stefan D Anker, MD, PhD
Address 0 0
University Medical Center Gottingen, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03499236