RELIEVE-HF: Reducing Lung CongestIon Symptoms in Advanced Heart Failure

Sponsor
V-Wave Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03499236
Collaborator
(none)
500
132
3
109.4
3.8
0

Study Details

Study Description

Brief Summary

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Condition or Disease Intervention/Treatment Phase
  • Device: V-Wave Interatrial Shunt
  • Other: Control
N/A

Detailed Description

This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 2 patients per site in an open-label study.Randomized treatment versus control (1:1). Control patients will be allowed to cross-over at the completion of the blinded phase. A parallel roll-in arm will enroll up to 2 patients per site in an open-label study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
In the randomized cohort, participants, the clinical team, and research staff managing the patient after randomization will be blinded to study assignment.
Primary Purpose:
Treatment
Official Title:
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Actual Study Start Date :
Sep 19, 2018
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Oct 31, 2027

Arms and Interventions

Arm Intervention/Treatment
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

Device: 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: 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.

Other: Control
Right heart catheterization, invasive echocardiography.

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

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Safety-Percentage of Treatment patients experiencing major device-related adverse events [30-days after randomization]

    Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal

  2. 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) [Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months]

    Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method

Secondary Outcome Measures

  1. 6MWT changes [Baseline to 12 months]

    6MWT changes

  2. KCCQ changes [Baseline to 12 months]

    KCCQ changes

  3. KCCQ changes [Baseline through study completion, maximum of five years]

    KCCQ changes

  4. Time to all-cause death, LVAD/Transplant, or heart failure hospitalization [Baseline through study completion, maximum of five years]

    Time to all-cause death, LVAD/Transplant, or heart failure hospitalization

  5. Time to all-cause death or first heart failure hospitalization [Baseline through study completion, maximum of five years]

    Time to all-cause death or first heart failure hospitalization

  6. Cumulative heart failure hospitalizations [Baseline through study completion, maximum of five years]

    Cumulative heart failure hospitalizations

  7. Time to first heart failure hospitalization [Baseline through study completion, maximum of five years]

    Time to first heart failure hospitalization

  8. Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ [Baseline through study completion, maximum of five years]

    Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Main Inclusion Criteria:
  • 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mercy Gilbert Medical Center Gilbert Arizona United States 85297
2 Abrazo Arizona Heart Hospital Phoenix Arizona United States 85016
3 Arizona Heart Rhythm Center Phoenix Arizona United States 85016
4 Central Cardiology Medical Center Bakersfield California United States 93308
5 Scripps Health La Jolla California United States 92037
6 Long Beach Memorial Medical Center Long Beach California United States 90806
7 Keck Medical Center of USC Los Angeles California United States 90033
8 Cedars Sinai Medical Center Los Angeles California United States 90211
9 Sutter Medical Center, Sacramento Sacramento California United States 95816
10 Foundation for Cardiovascular Medicine San Diego California United States 92122
11 Kaiser Permanente San Francisco San Francisco California United States 94118
12 University of California, San Francisco San Francisco California United States 94143
13 Stanford Hospital Stanford California United States 94305
14 Los Robles Hospital & Medical Center Thousand Oaks California United States 91360
15 The Lundquist Institute (Harbor-UCLA) Medical Center Torrance California United States 90502
16 South Denver Cardiology Littleton Colorado United States 80120
17 JFK Medical Center Atlantis Florida United States 33462
18 Morton Plant Mease Healthcare Clearwater Florida United States 33756
19 Delray Medical Center Delray Beach Florida United States 33484
20 Memorial Regional Hospital Hollywood Florida United States 33021
21 Memorial Hospital Jacksonville Florida United States 32216
22 University of Miami Hosptial Miami Florida United States 33136
23 First Coast Cardiovascular Institute Orange Park Florida United States 32003
24 AdventHealth Orlando Orlando Florida United States 32825
25 Piedmont Hospital Atlanta Georgia United States 30309
26 Atlanta VA Health System Decatur Georgia United States 30033
27 Northeast Georgia Medical Center Gainesville Georgia United States 30501
28 Rush University Medical Center Chicago Illinois United States 60612
29 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
30 Advocate Health and Hospitals Corporation (Edwards Hospital) Naperville Illinois United States 60540
31 Kansas City Cardiac Arrhythmia Research Overland Park Kansas United States 66211
32 Ascension Via Christi Wichita Kansas United States 67214
33 St Elizabeth Medical Center Edgewood Kentucky United States 41017
34 University of Kentucky Hospital Lexington Kentucky United States 40536
35 Cardiovascular Institute of the South Lafayette Louisiana United States 70596
36 The Johns Hopkins Medical Institutions Baltimore Maryland United States 21287
37 Ascension St. Mary's Hospital Saginaw Michigan United States 48601
38 United Heart & Vascular Clinic Saint Paul Minnesota United States 55102
39 Nebraska Heart Institute Lincoln Nebraska United States 68526
40 Valley Health System Ridgewood New Jersey United States 07450
41 Montefiore Medical Center Bronx New York United States 10467
42 St. Francis Hospital East Hills New York United States 11548
43 Northwell-Northshore University Hospital Manhasset New York United States 11030
44 Weill Cornell New York New York United States 10065
45 Northwell Health Lenox Hill Hospital New York New York United States 10075
46 Rochester General Health System Rochester New York United States 14621
47 University of Rochester Medical Center Rochester New York United States 14642
48 Mission Hospital Asheville North Carolina United States 28801
49 North Carolina Heart & Vascular Raleigh North Carolina United States 27607
50 Wakemed Raleigh North Carolina United States 27610
51 Summa Health Akron Ohio United States 44304
52 Lindner Center for Research and Education at The Christ Hospital Cincinnati Ohio United States 45219
53 Cleveland Clinic Cleveland Ohio United States 80120
54 The Ohio State University Columbus Ohio United States 43210
55 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
56 UPMC Pinnacle / Pinnacle Health Cardiovascular Institute Wormleysburg Pennsylvania United States 17043
57 Medical University of South Carolina Charleston South Carolina United States 29425
58 Stern Cardiovascular Foundation Germantown Tennessee United States 37205
59 University of Tennessee Medical Center Knoxville Tennessee United States 37920
60 Centennial Medical Center Nashville Tennessee United States 37203
61 Ascension St. Thomas West Nashville Tennessee United States 37205
62 Vanderbilt University Medical Center Nashville Tennessee United States 37232
63 Austin Heart Austin Texas United States 78756
64 Medical City Dallas Dallas Texas United States 75230
65 Baylor College of Medicine Houston Texas United States 77030
66 Texas Heart Institute Houston Texas United States 77030
67 University of Texas Memorial Hermann Houston Texas United States 77030
68 Baylor Scott & White The Heart Hospital Plano Texas United States 75093
69 Methodist Hospital San Antonio Texas United States 78249
70 Baylor Heart and Vascular-Dallas (Scott and White) -Temple Temple Texas United States 76508
71 Christus Mother Frances Hospital Tyler Texas United States 75701
72 University of Utah Hospital Salt Lake City Utah United States 84132
73 University of Virginia Charlottesville Virginia United States 22908
74 Inova Heart and Vascular Center Falls Church Virginia United States 22042
75 Sentara Heart Hospital Norfolk Virginia United States 23507
76 Chippenham Medical Center Richmond Virginia United States 23225
77 St. Vincent's Hospital Sydney Darlinghurst New South Wales Australia 2010
78 Flinders Medical Centre Adelaide Australia
79 Prince Charles Hospital Brisbane Australia
80 St. Vincent's Hospital Melbourne Australia
81 Epworth Hospital Richmond Australia
82 Algemeen Stedelijk Ziekenhuis Aalst Aalst Belgium
83 Antwerp Cardiovascular Center, ZNA Middelheim Hospital Antwerp Belgium
84 AZ Sint-Jan Brugge Brugge Belgium
85 Saint Luc Hospital Brussel Belgium
86 Toronto General Hospital Toronto Ontario Canada M5G2C4
87 McGill University Montréal Canada H4A 3J1
88 Montréal Heart Institute Montréal Canada
89 Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Québec Canada G1V 4G5
90 Herz- und Diabeteszentrum NRW Bad Oeynhausen Germany 32545
91 Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Berlin Germany 10117
92 Vivantes Klinikum im Friedrichshain Berlin Germany 10249
93 Vivantes Klinikum Urban Berlin Germany
94 Marienkrankrankenhas Hamburg Germany
95 Universitätsklinikum Leipzig Leipzig Germany 04103
96 Herzzentrum Leipzig Leipzig Germany 04289
97 Universitatsmedizin Mainz Mainz Germany 55131
98 Ludwig-Maximilians-Universität München München Germany 81377
99 SANA Remscheid Remscheid Germany
100 University of Rostock Rostock Germany
101 University Hospital Samson Assuta Ashdod Ashdod Israel 7747629
102 Yitzhak Shamir Medical Center Be'er Ya'aqov Israel
103 Soroka University Medical Center Beer-Sheva Israel 84101
104 Rambam Medical Center Haifa Israel 31906
105 Shaare Zedek Medical Center Jerusalem Israel 9103102
106 Hadassah Medical Center Jerusalem Israel
107 The Chaim Sheba Medical Center Tel-Hashomer Ramat Gan Israel 52621
108 Kaplan Medical Center Rechovot Israel
109 Tel Aviv Sourasky Medical Center Tel Aviv Israel
110 The Baruch Padeh Medical Center, Poriya Tiberias Israel 15208
111 St Antonius Ziekenhuis Nieuwegein Nieuwegein Utrecht Netherlands 3435
112 Academic Medical Center, The Netherlands Amsterdam Netherlands 1105
113 Erasmus University Medical Canter Rotterdam Rotterdam Netherlands 3015
114 Christchurch Hospital Christchurch New Zealand
115 Auckland Hospital Grafton New Zealand 1142
116 Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w Katowicach Katowice Poland 40-635
117 Oddział Kliniczny Kardiologii Interwencyjnej Kraków Poland
118 University Hospital Krakow Kraków Poland
119 Institute of Cardiology, Warsaw Warszawa Poland
120 The 4th Military Clinical Hospital Wroclaw Wrocław Poland
121 University Hospital Wroclaw Wrocław Poland
122 Hospital Clinic of Barcelona Barcelona Spain 08036
123 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041
124 Hospital Universitari Germans Trias i Pujol, Badalona Barcelona Barcelona Spain 08916
125 Hospital Clínico San Carlos Madrid Spain 28040
126 Hospital Puerta de Hierro-Majadahonda Madrid Spain 28222
127 University Hospital Virgen de la Arrixaca Murcia Spain 30120
128 Hospital Clínico Universitario de Valencia Valencia Spain 46010
129 Hospital Clínico Universitario de Valladolid Valladolid Spain 47003
130 Bern University Hospital Bern Switzerland 3010
131 Luzerner Kantonsspital Luzern Switzerland 6000
132 University Hospital of Zürich Zürich Switzerland 8091

Sponsors and Collaborators

  • V-Wave Ltd

Investigators

  • Principal Investigator: Stefan D Anker, MD, PhD, University Medical Center Gottingen, Germany
  • Principal Investigator: JoAnn Lindenfeld, MD, Vanderbilt University
  • Principal Investigator: Josep Rodés-Cabau, MD, Université Laval (CRIUCPQ-ULaval)
  • Principal Investigator: Gregg W Stone, MD, Colombia University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
V-Wave Ltd
ClinicalTrials.gov Identifier:
NCT03499236
Other Study ID Numbers:
  • CL7018
First Posted:
Apr 17, 2018
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022