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

Primary Purpose

Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

CardiAQ TMVI System (Transapical & Transfemoral DS)

About this trial

This is an interventional treatment trial for Mitral Insufficiency focused on measuring Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical, Transfemoral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

See Protocol

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CardiAQ TMVI System (Transapical & Transfemoral DS)

Arm Description

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Outcomes

Primary Outcome Measures

Composite Major Adverse Event Rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02515539

First Posted

August 3, 2015

Last Updated

March 29, 2016

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT02515539

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Edwards Lifesciences terminated the IDE associated with this study. No patients enrolled.

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease

Keywords

Transcatheter Mitral Valve Replacement, Mitral Regurgitation, Mitral Insufficiency, Transapical, Transfemoral

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CardiAQ TMVI System (Transapical & Transfemoral DS)

Arm Type

Experimental

Arm Description

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Intervention Type

Device

Intervention Name(s)

CardiAQ TMVI System (Transapical & Transfemoral DS)

Intervention Description

CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Primary Outcome Measure Information:

Title

Composite Major Adverse Event Rate

Time Frame

30-Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Exclusion Criteria: See Protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilson Szeto, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Howard Herrmann, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Saibal Kar, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alfredo Trento, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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