REDUCE LAP-HF TRIAL II
- Conditions
- Heart Failure
- Interventions
- Device: IASD System II implantOther: intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
- Registration Number
- NCT03088033
- Lead Sponsor
- Corvia Medical
- Brief Summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
- Detailed Description
Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group.
All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization.
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Patients will be evaluated at pre-specified time intervals and followed for 5 years.
All patients will be unblinded after the 24 month follow up visit.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 608
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment IASD System II implant Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Control intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
- Primary Outcome Measures
Name Time Method Composite Primary Endpoint Up to 24 months The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
- Secondary Outcome Measures
Name Time Method Change in Kansas City Cardiomyopathy Questionnaire 12 months Change in KCCQ score between baseline and 12 months, categorized as ≤0, \>0 - 5, \>5 - 10, \>10 - 15, \>15 - 20, \>20 - 25, \>25.
Change in NYHA Class 12 months Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
Rate of heart failure admissions Up to 24 months Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up
Composite safety endpoint defined as follows: 12 months 1. Cardiovascular mortality
2. Non-fatal, ischemic stroke
3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min)
4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery
5. Thrombo-embolic complications (TIA, systemic embolization)
6. Newly acquired persistent or permanent AF or atrial flutter through
7. ≥30% increase in RV size/decrease in TAPSE
Trial Locations
- Locations (91)
Kaiser Permanente San Diego
🇺🇸La Jolla, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
St. Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hamilton, New Jersey, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Ohio Health
🇺🇸Columbus, Ohio, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
John Hunter Hospital
🇦🇺Newcastle, New South Wales, Australia
CHU de Rennes
🇫🇷Rennes, France
The Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
Universitatklinikum Duseldorf
🇩🇪Dusseldorf, Germany
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Az Sint-Jan Brugge
🇧🇪Brugge, Belgium
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Medizinische Universität Graz
🇦🇹Graz, Austria
OLVZ Aalst
🇧🇪Aalst, Belgium
University Hospital Center, Zagreb
🇭🇷Zagreb, Croatia
CHU de Dijon
🇫🇷Dijon, France
CHU de Nantes
🇫🇷Nantes, France
Hôpital Bichat
🇫🇷Paris, France
Hôpital La Pitié Salpétrière
🇫🇷Paris, France
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
CHU de Rouen
🇫🇷Rouen, France
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany
Heart Center Freiburg University
🇩🇪Freiburg, Germany
Georg-August-Universitat
🇩🇪Gottingen, Germany
Cardiologicum CRC
🇩🇪Hamburg, Germany
UKE Hamburg
🇩🇪Hamburg, Germany
University of Heidelberg
🇩🇪Heidelberg, Germany
University of Milano
🇮🇹Milano, Italy
Klinikum der Universität Munchen
🇩🇪Munich, Germany
Heart Center of the University of Leipzig
🇩🇪Leipzig, Germany
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
The Hospital of Hyogo College of Medicine
🇯🇵Hyōgo, Japan
National Cerebral and Cardiovascular Center
🇯🇵Osaka, Japan
Nara Medical University Hospital
🇯🇵Nara, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
The University of Tokyo Hospital
🇯🇵Tokyo, Japan
Tottori University Hospital
🇯🇵Tottori, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
VU University Medical Center
🇳🇱Amsterdam, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Maastricht UMC Hart & Vaat Centrum
🇳🇱Maastricht, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Fourth Military Hospital
🇵🇱Wroclaw, Poland
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Golden Jubilee Hospital
🇬🇧Glasgow, United Kingdom
Guys & St Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Concord Hospital
🇦🇺Camperdown, New South Wales, Australia
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Tallahassee Research Institute, Inc.
🇺🇸Tallahassee, Florida, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Ohio State University College of Medicine
🇺🇸Columbus, Ohio, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Evanston Northshore Healthcare
🇺🇸Evanston, Illinois, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center, Dallas
🇺🇸Dallas, Texas, United States
St. Vincent Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Tufts New England Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Christ Hospital Ohio Heart and Vascular Institute
🇺🇸Cincinnati, Ohio, United States
Rigshospitalet
🇩🇰Copenhagen, Denmark
Kaiser Permanente San Francisco Medical Center
🇺🇸San Francisco, California, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States