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

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02515539

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Insufficiency Heart Valve Disease Cardiovascular Disease Heart Disease	Device: CardiAQ TMVI System (Transapical & Transfemoral DS)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems)

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CardiAQ TMVI System (Transapical & Transfemoral DS) CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System	Device: CardiAQ TMVI System (Transapical & Transfemoral DS) CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Arm

Intervention/Treatment

Experimental: CardiAQ TMVI System (Transapical & Transfemoral DS)

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Device: CardiAQ TMVI System (Transapical & Transfemoral DS)

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Outcome Measures

Primary Outcome Measures

Composite Major Adverse Event Rate [30-Day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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