Heart Failure Clinical Trial

REDUCE LAP-HF TRIAL II

Summary

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

SELECT INCLUSION CRITERIA

Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

Symptoms of HF requiring current treatment with diuretics for ≥ 30 days AND
NYHA class II with a history of > NYHA class II; OR NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure (with no significant changes [>100% increase or 50% decrease], excluding diuretic dose change for a minimum of 4 weeks prior to screening) that is expected to be maintained without change for 6 months
Age ≥ 40 years old, LV ejection fraction (EF) ≥ 40% within the past 3 months, without previously documented EF <30% (within the past 3 years)
Elevated PCWP with a gradient compared to right atrial pressure (RAP), documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mmHg, and greater than RAP by ≥ 5 mmHg

SELECT EXCLUSION CRITERIA

MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
Cardiac Resynchronization Therapy initiated within the past 6 months

Advanced heart failure defined as one or more of the below:

ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF;
Cardiac index < 2.0 L/min/m2
Inotropic infusion (continuous or intermittent) for EF< 40% within the past 6 months
Patient is on the cardiac transplant waiting list
Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months

Presence of significant valve disease defined by the site cardiologist as:

Mitral valve regurgitation defined as grade ≥ 3+ MR
Tricuspid valve regurgitation defined as grade ≥ 2+ TR
Aortic valve disease defined as ≥ 2+ AR or > moderate AS
Known clinically significant untreated carotid artery stenosis likely to require intervention
Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

Study is for people with:

Heart Failure

Estimated Enrollment:

608

Study ID:

NCT03088033

Recruitment Status:

Active, not recruiting

Sponsor:

Corvia Medical

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There are 48 Locations for this study

See Locations Near You

Arizona Cardiovascular Research Center
Phoenix Arizona, 85016, United States
University of Arizona College of Medicine
Tucson Arizona, 85724, United States
Scripps Clinic
La Jolla California, 92037, United States
Kaiser Permanente San Diego
La Jolla California, 92120, United States
Kaiser Permanente San Francisco Medical Center
San Francisco California, 94115, United States
South Denver Cardiology Associates
Littleton Colorado, 80120, United States
Yale University
New Haven Connecticut, 06510, United States
Medstar Washington Hospital Center
Washington District of Columbia, 20010, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33307, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Tallahassee Research Institute, Inc.
Tallahassee Florida, 33208, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Evanston Northshore Healthcare
Evanston Illinois, 60201, United States
Cardiovascular Institute of the South
Houma Louisiana, 70360, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Tufts New England Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
University of Michigan Health System
Ann Arbor Michigan, 41809, United States
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
St. Louis Heart and Vascular
Saint Louis Missouri, 63136, United States
Hackensack University Medical Center
Hamilton New Jersey, 08690, United States
Morristown Memorial Hospital
Morristown New Jersey, 07962, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest
Winston-Salem North Carolina, 27157, United States
Christ Hospital Ohio Heart and Vascular Institute
Cincinnati Ohio, 45219, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University College of Medicine
Columbus Ohio, 43210, United States
Ohio Health
Columbus Ohio, 43214, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17602, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
UPMC Presbyterian Hospital
Pittsburgh Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Vanderbilt University
Nashville Tennessee, 37242, United States
Baylor University Medical Center, Dallas
Dallas Texas, 75246, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
Intermountain Medical Center
Murray Utah, 84157, United States
University of Utah Medical Center
Salt Lake City Utah, 84132, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Virginia Commonwealth University Medical Center
Richmond Virginia, 23298, United States
Concord Hospital
Camperdown New South Wales, 2050, Australia
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia
John Hunter Hospital
Newcastle New South Wales, 2305, Australia
St. Vincent Hospital
Sydney New South Wales, 2010, Australia
The Prince Charles Hospital
Brisbane Queensland, 4032, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Medizinische Universität Graz
Graz , , Austria
OLVZ Aalst
Aalst , , Belgium
Az Sint-Jan Brugge
Brugge , , Belgium
Hamilton Health Sciences
Hamilton Ontario, , Canada
University Hospital Center, Zagreb
Zagreb , , Croatia
Rigshospitalet
Copenhagen , , Denmark
CHU de Dijon
Dijon , , France
CHU de Nantes
Nantes , , France
Hôpital Bichat
Paris , , France
Hôpital La Pitié Salpétrière
Paris , , France
CHU de Rennes
Rennes , , France
CHU de Rouen
Rouen , , France
Kerckhoff Klinik
Bad Nauheim , , Germany
Charite Universitatsmedizin Berlin
Berlin , , Germany
Unfallkrankenhaus Berlin
Berlin , , Germany
Universitatklinikum Duseldorf
Dusseldorf , , 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
Heart Center of the University of Leipzig
Leipzig , , Germany
Klinikum der Universität Munchen
Munich , , Germany
University of Milano
Milano , , Italy
Hokkaido University Hospital
Sapporo Hokkaido, , Japan
Kyushu University Hospital
Fukuoka , , Japan
The Hospital of Hyogo College of Medicine
Hyōgo , , Japan
Nara Medical University Hospital
Nara , , Japan
National Cerebral and Cardiovascular Center
Osaka , , 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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

608

Study ID:

NCT03088033

Recruitment Status:

Active, not recruiting

Sponsor:


Corvia Medical

How clear is this clinincal trial information?

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