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ACTIVE NOT RECRUITING
NCT03093961
NA

REDUCE LAP-HFREF TRIAL

Sponsor: 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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2017-03-10

Completion Date

2027-12

Last Updated

2024-02-06

Healthy Volunteers

No

Conditions

Interventions

DEVICE

IASD implant

Single arm for implant

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