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OpenTrials
Completed

NCT Number: NCT03988946

Cephea Transseptal Mitral Valve System FIH

To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital

Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

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

MVARC

Treatment and study plan

Transcatheter Mitral Valve Replacement via Transseptal Access

Device

The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.

Primary outcomes

  1. Safety as measured by freedom from major adverse events

    Time frame: 30 days

    Freedom from major adverse events, including:

    • All-cause mortality
    • Disabling stroke
    • Myocardial infarction
    • Renal failure requiring dialysis
    • Life-threatening bleeding
    • Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.

  2. Performance

    Time frame: 30 days

    Reduction in mitral regurgitation to ≤1+

Sponsors and collaborators

Lead sponsor

Cephea Valve Technologies

Industry

Registry information

Official study title

Cephea Mitral Valve and Transseptal Delivery System FIH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2019
Registry last updated
Jan 23, 2020

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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