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

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03191656

Acronym

REDUCELAPHFIII

Enrollment

500

Registered

2017-06-19

Start date

2017-03-12

Completion date

2028-07-31

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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.

Interventions

DEVICEIASD Implant

Implantation of the IASD device using trans-septal puncture and the IASD system

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events	30 days	Device and or procedure related serious adverse cardiac events
New York Heart Classification	12 months	Improvement in NYHA Classification
Quality of Life Improvement (KCCQ score)	12 months	Improvement in KCCQ score
Quality of Life Improvement (EQ5D)	12 months	Improvement in EQ5D score

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026