Trials / Recruiting
RecruitingNCT03191656
REDUCE LAP-HF III Corvia Protocol 1701
A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Corvia Medical · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IASD Implant | Implantation of the IASD device using trans-septal puncture and the IASD system |
Timeline
- Start date
- 2017-07-12
- Primary completion
- 2026-07-31
- Completion
- 2028-07-31
- First posted
- 2017-06-19
- Last updated
- 2024-02-08
Locations
27 sites across 2 countries: Germany, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03191656. Inclusion in this directory is not an endorsement.