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

NCT ID: NCT02515539

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2021-07-31

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.

Conditions

Mitral Insufficiency; Heart Valve Disease; Cardiovascular Disease; Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CardiAQ TMVI System (Transapical & Transfemoral DS)

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Group Type: EXPERIMENTAL

CardiAQ TMVI System (Transapical & Transfemoral DS)

Intervention Type: DEVICE

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Interventions

CardiAQ TMVI System (Transapical & Transfemoral DS)

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Szeto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Howard Herrmann, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Saibal Kar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Alfredo Trento, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Other Identifiers

CIP-3103-01

Identifier Type: -

Identifier Source: org_study_id