🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT03088033
Active, not recruiting Not applicable

REDUCE LAP-HF TRIAL II

NCT03088033 · tracked via the Priya Life Science USA tracker
Sponsor
Corvia Medical
Phase
Not applicable
Started
2017-06-01
Last updated
2023-02-22

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

IASD System II implantintra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)

IASD System II implant: The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.

intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE): intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Arizona Cardiovascular Research Center Phoenix Arizona
University of Arizona College of Medicine Tucson Arizona
Scripps Clinic La Jolla California
Kaiser Permanente San Diego La Jolla California
Kaiser Permanente San Francisco Medical Center San Francisco California
South Denver Cardiology Associates Littleton Colorado
Yale University New Haven Connecticut
Medstar Washington Hospital Center Washington D.C. District of Columbia
Holy Cross Hospital Fort Lauderdale Florida
Sarasota Memorial Hospital Sarasota Florida
Tallahassee Research Institute, Inc. Tallahassee Florida
Cleveland Clinic Florida Weston Florida
Northwestern University Chicago Illinois
University of Chicago Medical Center Chicago Illinois
Evanston Northshore Healthcare Evanston Illinois
Cardiovascular Institute of the South Houma Louisiana
Ochsner Clinic Foundation New Orleans Louisiana
Tufts New England Medical Center Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
University of Michigan Health System Ann Arbor Michigan
Minneapolis Heart Institute Foundation Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
St. Louis Heart and Vascular St Louis Missouri
Hackensack University Medical Center Hamilton New Jersey
Morristown Memorial Hospital Morristown New Jersey
Duke University Medical Center Durham North Carolina
Wake Forest Winston-Salem North Carolina
Christ Hospital Ohio Heart and Vascular Institute Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
Ohio State University College of Medicine Columbus Ohio
Ohio Health Columbus Ohio
Lancaster General Hospital Lancaster Pennsylvania
University of Pennsylvania Philadelphia Pennsylvania
UPMC Presbyterian Hospital Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Vanderbilt University Nashville Tennessee
Baylor University Medical Center, Dallas Dallas Texas
Baylor College of Medicine Houston Texas
Houston Methodist Hospital Houston Texas
University of Texas Health Science Center at San Antonio San Antonio Texas

+ 51 more sites — see the full list on the official registry below.

More Corvia Medical trials in the USA

REDUCE LAP-HFREF TRIAL Active, not recruiting
RESPONDER-HF Trial Active, not recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03088033 on ClinicalTrials.gov ↗ ← All trials in the USA