RELIEVE-HF: Reducing Lung CongestIon Symptoms in Advanced Heart Failure
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 |
---|---|---|
|
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
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
- 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
- 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
- 6MWT changes [Baseline to 12 months]
6MWT changes
- KCCQ changes [Baseline to 12 months]
KCCQ changes
- KCCQ changes [Baseline through study completion, maximum of five years]
KCCQ changes
- 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
- 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
- Cumulative heart failure hospitalizations [Baseline through study completion, maximum of five years]
Cumulative heart failure hospitalizations
- Time to first heart failure hospitalization [Baseline through study completion, maximum of five years]
Time to first heart failure hospitalization
- 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
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.- CL7018