A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

Not Applicable

Terminated

• Conditions: Mitral Insufficiency; Heart Disease; Heart Valve Disease; Cardiovascular Disease
• Interventions: Device: CardiAQ TMVI System (Transapical DS)

• 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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• NYHA Classification ≥ III
• Left Ventricular Ejection Fraction ≥ 30%
• Mitral regurgitation ≥ Grade 3+
• Subject meets anatomical eligibility criteria for the investigational device

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardiAQ TMVI System (Transapical DS)	CardiAQ TMVI System (Transapical DS)	-

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Event Rate	12-Month

Trial Locations

Locations (9)

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

New Cross Hospital Heart Center; 🇬🇧 Wolverhampton, United Kingdom

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Rigshospitalet University Hospital; 🇩🇰 Copenhagen, Denmark