Heart Failure Clinical Trial

REDUCE LAP-HF RANDOMIZED TRIAL I

Summary

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

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Full Description

The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Chronic symptomatic Heart Failure
Ongoing stable GDMT HF management and management of potential comorbidities
Age ≥ 40 years old
LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg

Key Exclusion Criteria:

MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
Cardiac Resynchronization Therapy initiated within the past 6 months
Severe heart failure
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
Known clinically significant untreated carotid artery stenosis
Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation

Study is for people with:

Heart Failure

Estimated Enrollment:

44

Study ID:

NCT02600234

Recruitment Status:

Active, not recruiting

Sponsor:

Corvia Medical

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There are 7 Locations for this study

See Locations Near You

University of Arizona College of Medicine
Tucson Arizona, 85724, United States
Yale University
New Haven Connecticut, 06510, United States
Northwestern University
Chicago Illinois, 60611, United States
Evanston Northshore Healthcare
Evanston Illinois, 60201, United States
Cardiovascular Institute of the South
Houma Louisiana, , United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, , United States
University of Michigan Health System
Ann Arbor Michigan, 41809, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
New York New York, , United States
Mt. Sinai Hospital
New York New York, , United States
New York University
New York New York, , United States
Wake Forest
Winston-Salem North Carolina, , United States
Ohio Health
Columbus Ohio, , United States
Ohio State University College of Medicine
Columbus Ohio, , United States
University of Pennsylvania
Philadelphia Pennsylvania, , United States
Medical University of South Carolina
Charleston South Carolina, , United States
The Alfred Hospital
Melbourne , , Australia
OLVZ Aalst
Aalst , , Belgium
UMC Groningen
Groningen , , Netherlands
Golden Jubilee Hospital
Glasgow , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

44

Study ID:

NCT02600234

Recruitment Status:

Active, not recruiting

Sponsor:


Corvia Medical

How clear is this clinincal trial information?

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