A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

March 29, 2016 updated by: Edwards Lifesciences

A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet University Hospital
  • France
      • Lille, France
        • Centre Hospitalier Regional Universitaire de Lille
      • Paris, France
        • Hôpital Européen Georges-Pompidou
      • Toulouse, France
        • Centre Hospitalier Universiatier de Toulouse
  • Netherlands
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus University Medical Center
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Wolverhampton, United Kingdom
        • New Cross Hospital Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CardiAQ TMVI System (Transapical DS)
Device: CardiAQ TMVI System (Transapical DS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite Major Adverse Event Rate
Time Frame: 30-Day
30-Day
Composite Major Adverse Event Rate
Time Frame: 12-Month
12-Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Lars Søndergaard, MD, DMSc, Rigshospitalet University Hospital (Copenhagen, Denmark)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-3102-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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