A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
- Conditions
- Mitral InsufficiencyHeart DiseaseHeart Valve DiseaseCardiovascular Disease
- Registration Number
- NCT02478008
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- NYHA Classification ≥ III
- Left Ventricular Ejection Fraction ≥ 30%
- Mitral regurgitation ≥ Grade 3+
- Subject meets anatomical eligibility criteria for the investigational device
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Composite Major Adverse Event Rate 12-Month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Rigshospitalet University Hospital
🇩🇰Copenhagen, Denmark
Centre hospitalier régional universitaire de Lille
🇫🇷Lille, France
Hôpital Européen Georges-Pompidou
🇫🇷Paris, France
Centre Hospitalier Universiatier de Toulouse
🇫🇷Toulouse, France
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
New Cross Hospital Heart Center
🇬🇧Wolverhampton, United Kingdom
Rigshospitalet University Hospital🇩🇰Copenhagen, Denmark