Overview

This trial is active, not recruiting.

Condition heart failure
Treatment iasd
Sponsor Corvia Medical
Start date September 2013
End date December 2015
Trial size 100 participants
Trial identifier NCT01913613, 2013-01

Summary

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment with the IASD device
iasd
IASD device implantation

Primary Outcomes

Measure
MACCE
time frame: 6 months

Eligibility Criteria

Male or female participants at least 40 years old.

Key Inclusion Criteria: 1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following: 1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; 2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify); 3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure). 2. Age ≥ 40 years old 3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40% 4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by : 1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR 2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg Key Exclusion Criteria: 3. Severe heart failure defined as: 1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF; 2. Fick Cardiac Index < 2.0 L/min/m2 3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months 4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis >70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade >2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS

Additional Information

Official title REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Corvia Medical.