Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)

Not Applicable

Withdrawn

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

• Registration Number: NCT02515539
• Lead Sponsor: Edwards Lifesciences

Brief Summary

The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Detailed Description

Early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls.

The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.

The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.

The study is to be performed at a maximum of 5 investigational sites in the US.

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-04
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31
• Primary Completion: 2016-08
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• See Protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardiAQ TMVI System (Transapical & Transfemoral DS)	CardiAQ TMVI System (Transapical & Transfemoral DS)	CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Event Rate	30-Day