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REDUCE LAP-HFREF TRIAL | Clinical Trials | Clareo Health

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REDUCE LAP-HFREF TRIAL

A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure With Reduced Ejection Fraction

NCT03093961•Corvia Medical

View on ClinicalTrials.gov

Summary

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Detailed Description

The intended clinical indication of the IASD System II is the reduction of elevated LAP in patients with symptomatic heart failure with reduced ejection fraction, despite appropriate medical management. The implant is designed with a center barrel opening that, in the setting of elevated LAP, allows left to right flow. Since many of the symptoms these patients experience are believed to be due to elevated LAP, the IASD System II has the potential to significantly reduce symptoms and improve the quality of life in patients with otherwise limited treatment options. The study design is a prospective, non-randomized, single-arm feasibility trial. This study will implant up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI). After analysis of the 1 month results (including baseline and 1 month Core laboratory echocardiographic and hemodynamic data) of the first 5 implanted patients, a decision will be made to implant an additional 5 patients,

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Chronic symptomatic Heart Failure (HF) documented by the following:
•1. New York Heart Association (NYHA) Class III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit, and signs (e.g. any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
•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), or one emergency department visit with IV treatment for HF within the 12 months prior to study entry
•2. Ongoing stable GDMT for HF (Class I, and IIa recommendations) according to the 2016 ACC/AHA Guidelines for the management of Heart Failure (with no significant changes \[\>100% increase or 50% decrease\], excluding diuretic dose changes for a minimum of 3 months prior to screening), which is expected to be maintained without change for 6 months
•3. Age ≥ 18 years old
•4. Reduced Left ventricular ejection fraction between 20% and 40% as documented by echocardiography, radio nuclide ventriculography, or MRI within the past 3 months
•5. Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by:
•a. Resting end expiratory PCWP ≥ 18 mmHg, and greater than RAP by ≥ 5 mmHg
•6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, as approved by the IRB
•7. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
+1 more criteria

Exclusion Criteria

•1. Patients who are not receiving GDMT for specified reasons
•2. NT-Pro BNP \< 100 pg/mL (if in sinus rhythm), or \<300 pg/mL (if in atrial fibrillation); or BNP \< 70 pg/mL (if in sinus rhythm), or \< 200 pg/mL (if in atrial fibrillation)
•3. Myocardial infarction (MI) and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
•4. Cardiac Resynchronization Therapy initiated within the past 3 months
•5. Automated Implantable Cardioverter Defibrillator (AICD) placed within past 3 months
•6. Severe heart failure defined by all of the following:
•1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
•2. Cardiac Index \< 2.0 L/min/m2
•3. Requiring inotropic infusion (continuous or intermittent) within the past 3 months.
•4. Listed on transplant waiting list
+29 more criteria

Locations (4)

Mt. Sinai Hospital

New York, New York, United States

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

St. Vincent Hospital

Sydney, Australia

Homolka Hospital

Prague, Czechia

Key Dates

Start Date

March 10, 2017

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

February 6, 2024

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

IASD implant

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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REDUCE LAP-HFREF TRIAL

Inclusion Criteria

Exclusion Criteria

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