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
Enrollment
123
Locations
3
Arms
99.4
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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 400 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 :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

ArmIntervention/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, and change in Kansas City Cardiomyopathy Quesstionnaire (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 and HF Hospitalizations but without KCCQ [Baseline through study completion, maximum of five years]

    Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant and HF Hospitalizations 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

SiteCityStateCountryPostal Code
1Mercy Gilbert Medical CenterGilbertArizonaUnited States85297
2Abrazo Arizona Heart HospitalPhoenixArizonaUnited States85016
3Arizona Heart Rhythm CenterPhoenixArizonaUnited States85016
4Central Cardiology Medical CenterBakersfieldCaliforniaUnited States93308
5Scripps HealthLa JollaCaliforniaUnited States92037
6Long Beach Memorial Medical CenterLong BeachCaliforniaUnited States90806
7Keck Medical Center of USCLos AngelesCaliforniaUnited States90033
8Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90211
9Sutter Medical Center, SacramentoSacramentoCaliforniaUnited States95816
10Foundation for Cardiovascular MedicineSan DiegoCaliforniaUnited States92122
11Kaiser Permanente San FranciscoSan FranciscoCaliforniaUnited States94118
12University of California, San FranciscoSan FranciscoCaliforniaUnited States94143
13Stanford HospitalStanfordCaliforniaUnited States94305
14Los Robles Hospital & Medical CenterThousand OaksCaliforniaUnited States91360
15The Lundquist Institute (Harbor-UCLA) Medical CenterTorranceCaliforniaUnited States90502
16South Denver CardiologyLittletonColoradoUnited States80120
17JFK Medical CenterAtlantisFloridaUnited States33462
18Morton Plant Mease HealthcareClearwaterFloridaUnited States33756
19Delray Medical CenterDelray BeachFloridaUnited States33484
20Memorial Regional HospitalHollywoodFloridaUnited States33021
21Memorial HospitalJacksonvilleFloridaUnited States32216
22University of Miami HosptialMiamiFloridaUnited States33136
23First Coast Cardiovascular InstituteOrange ParkFloridaUnited States32003
24AdventHealth OrlandoOrlandoFloridaUnited States32825
25Atlanta VA Health SystemDecaturGeorgiaUnited States30033
26Rush University Medical CenterChicagoIllinoisUnited States60612
27Advocate Illinois Masonic Medical CenterChicagoIllinoisUnited States60657
28Advocate Health and Hospitals Corporation (Edwards Hospital)NapervilleIllinoisUnited States60540
29Kansas City Cardiac Arrhythmia ResearchOverland ParkKansasUnited States66211
30Ascension Via ChristiWichitaKansasUnited States67214
31St Elizabeth Medical CenterEdgewoodKentuckyUnited States41017
32University of Kentucky HospitalLexingtonKentuckyUnited States40536
33Cardiovascular Institute of the SouthLafayetteLouisianaUnited States70596
34The Johns Hopkins Medical InstitutionsBaltimoreMarylandUnited States21287
35Ascension St. Mary's HospitalSaginawMichiganUnited States48601
36United Heart & Vascular ClinicSaint PaulMinnesotaUnited States55102
37Nebraska Heart InstituteLincolnNebraskaUnited States68526
38Valley Health SystemRidgewoodNew JerseyUnited States07450
39Montefiore Medical CenterBronxNew YorkUnited States10467
40St. Francis HospitalEast HillsNew YorkUnited States11548
41Northwell-Northshore University HospitalManhassetNew YorkUnited States11030
42Weill CornellNew YorkNew YorkUnited States10065
43Rochester General Health SystemRochesterNew YorkUnited States14621
44University of Rochester Medical CenterRochesterNew YorkUnited States14642
45Mission HospitalAshevilleNorth CarolinaUnited States28801
46North Carolina Heart & VascularRaleighNorth CarolinaUnited States27607
47WakemedRaleighNorth CarolinaUnited States27610
48Summa HealthAkronOhioUnited States44304
49Lindner Center for Research and Education at The Christ HospitalCincinnatiOhioUnited States45219
50Cleveland ClinicClevelandOhioUnited States80120
51The Ohio State UniversityColumbusOhioUnited States43210
52Penn State Milton S. Hershey Medical CenterHersheyPennsylvaniaUnited States17033
53UPMC Pinnacle / Pinnacle Health Cardiovascular InstituteWormleysburgPennsylvaniaUnited States17043
54Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
55Stern Cardiovascular FoundationGermantownTennesseeUnited States37205
56University of Tennessee Medical CenterKnoxvilleTennesseeUnited States37920
57Centennial Medical CenterNashvilleTennesseeUnited States37203
58Ascension St. Thomas WestNashvilleTennesseeUnited States37205
59Vanderbilt University Medical CenterNashvilleTennesseeUnited States37232
60Austin HeartAustinTexasUnited States78756
61Baylor Heart and Vascular-Dallas (Scott and White)DallasTexasUnited States75093
62Medical City DallasDallasTexasUnited States75230
63University of Texas Memorial HermannHoustonTexasUnited States77030
64Baylor Scott & White The Heart HospitalPlanoTexasUnited States75093
65Methodist HospitalSan AntonioTexasUnited States78249
66Christus Mother Frances HospitalTylerTexasUnited States75701
67University of Utah HospitalSalt Lake CityUtahUnited States84132
68University of VirginiaCharlottesvilleVirginiaUnited States22908
69Inova Heart and Vascular CenterFalls ChurchVirginiaUnited States22042
70Sentara Heart HospitalNorfolkVirginiaUnited States23507
71Chippenham Medical CenterRichmondVirginiaUnited States23225
72St. Vincent's Hospital SydneyDarlinghurstNew South WalesAustralia2010
73Flinders Medical CentreAdelaideAustralia
74Prince Charles HospitalBrisbaneAustralia
75St. Vincent's HospitalMelbourneAustralia
76Epworth HospitalRichmondAustralia
77Algemeen Stedelijk Ziekenhuis AalstAalstBelgium
78Antwerp Cardiovascular Center, ZNA Middelheim HospitalAntwerpBelgium
79AZ Sint-Jan BruggeBruggeBelgium
80Saint Luc HospitalBrusselBelgium
81Toronto General HospitalTorontoOntarioCanadaM5G2C4
82McGill UniversityMontréalCanadaH4A 3J1
83Montréal Heart InstituteMontréalCanada
84Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalQuébecCanadaG1V 4G5
85Charité - Universitätsmedizin Berlin Campus Virchow-KlinikumBerlinGermany10117
86Vivantes Klinikum im FriedrichshainBerlinGermany10249
87Vivantes Klinikum UrbanBerlinGermany
88MarienkrankrankenhasHamburgGermany
89Universitätsklinikum LeipzigLeipzigGermany04103
90Herzzentrum LeipzigLeipzigGermany04289
91Universitatsmedizin MainzMainzGermany55131
92Ludwig-Maximilians-Universität MünchenMünchenGermany81377
93SANA RemscheidRemscheidGermany
94University of RostockRostockGermany
95University Hospital Samson Assuta AshdodAshdodIsrael7747629
96Yitzhak Shamir Medical CenterBe'er Ya'aqovIsrael
97Shaare Zedek Medical CenterJerusalemIsrael9103102
98Hadassah Medical CenterJerusalemIsrael
99The Chaim Sheba Medical Center Tel-HashomerRamat GanIsrael52621
100Kaplan Medical CenterRechovotIsrael
101Tel Aviv Sourasky Medical CenterTel AvivIsrael
102The Baruch Padeh Medical Center, PoriyaTiberiasIsrael15208
103St Antonius Ziekenhuis NieuwegeinNieuwegeinUtrechtNetherlands3435
104Academic Medical Center, The NetherlandsAmsterdamNetherlands1105
105Erasmus University Medical Canter RotterdamRotterdamNetherlands3015
106Christchurch HospitalChristchurchNew Zealand
107Górnośląskie Centrum Medyczne, Uniwersytetu Medycznego w KatowicachKatowicePoland40-635
108Oddział Kliniczny Kardiologii InterwencyjnejKrakówPoland
109University Hospital KrakowKrakówPoland
110Institute of Cardiology, WarsawWarszawaPoland
111The 4th Military Clinical Hospital WroclawWrocławPoland
112University Hospital WroclawWrocławPoland
113Hospital Clinic of BarcelonaBarcelonaSpain08036
114Hospital de la Santa Creu i Sant PauBarcelonaSpain08041
115Hospital Universitari Germans Trias i Pujol, Badalona BarcelonaBarcelonaSpain08916
116Hospital Clínico San CarlosMadridSpain28040
117Hospital Puerta de Hierro-MajadahondaMadridSpain28222
118University Hospital Virgen de la ArrixacaMurciaSpain30120
119Hospital Clínico Universitario de ValenciaValenciaSpain46010
120Hospital Clínico Universitario de ValladolidValladolidSpain47003
121Bern University HospitalBernSwitzerland3010
122Luzerner KantonsspitalLuzernSwitzerland6000
123University Hospital of ZürichZürichSwitzerland8091

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:
Oct 13, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Oct 13, 2021