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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02515539
• Other study ID #: CIP-3103-01
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2015
• Last updated: August 20, 2015
• Start date: August 2015
• Est. completion date: July 2021

Study information

• Verified date: August 2015
• Source: CardiAQ Valve Technologies, Inc.
• Contact: Paul Cornelison
• Phone: 949-537-3842
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2021
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Disease
• Heart Valve Disease
• Heart Valve Diseases
• Mitral Insufficiency
• Mitral Valve Insufficiency

Intervention

Device:
• CardiAQ TMVI System (Transapical & Transfemoral DS)
CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CardiAQ Valve Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Major Adverse Event Rate		30-Day	Yes