REDUCE LAP-HF III Corvia Protocol 1701 (REDUCELAPHFIII)

Corvia Medical

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: IASD Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT03191656

1701

Details and patient eligibility

About

This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.

Enrollment: 500 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

This is a post market registry so no criteria requirements (only recommendations).