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NCT Number: NCT03191656

REDUCE LAP-HF III Corvia Protocol 1701

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzzentrum der Kerckhoff-Klinik, Bad Nauheim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IASD implant

Device

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

Primary outcomes

  1. Serious Adverse Events

    Time frame: 30 days

    Device and or procedure related serious adverse cardiac events

  2. New York Heart Classification

    Time frame: 12 months

    Improvement in NYHA Classification

  3. Quality of Life Improvement (KCCQ score)

    Time frame: 12 months

    Improvement in KCCQ score

  4. Quality of Life Improvement (EQ5D)

    Time frame: 12 months

    Improvement in EQ5D score

Sponsors and collaborators

Lead sponsor

Corvia Medical

Industry

Registry information

Official study title

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

Acronym: REDUCELAPHFIII

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
Jun 19, 2017
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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