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Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve Replacement (TMVR) Early Feasibility Study

This study is currently recruiting participants.
Verified September 2017 by Edwards Lifesciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02718001
First Posted: March 24, 2016
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Edwards Lifesciences
March 1, 2016
March 24, 2016
September 4, 2017
February 2015
December 2017   (Final data collection date for primary outcome measure)
Safety assessed by freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
Safety assessed by freedom from device- or procedure-related adverse events
Same as current
Complete list of historical versions of study NCT02718001 on ClinicalTrials.gov Archive Site
  • NYHA functional class [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class
  • Six minute walk test [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Increase in distance (m) from baseline
  • Reduction in MR grade [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with reduction in MR grade from baseline
Same as current
Not Provided
Not Provided
 
Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve Replacement (TMVR) Early Feasibility Study
Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation
Early feasibility study to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and function of the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve with the Transfemoral and Transapical Delivery Systems.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mitral Valve Regurgitation (Degenerative or Functional)
Device: Transcatheter Mitral Valve Replacement (TMVR)
Replacement of the mitral valve through a transcatheter approach
Other Names:
  • CardiAQ™ Transcatheter Mitral Valve (TMV)
  • Edwards FORTIS™ Transcatheter Mitral Valve (TMV)
Experimental: Treatment
Treatment with the Edwards Lifesciences CardiAQ™ Transcatheter Mitral Valve (transapical or transfemoral delivery)
Intervention: Device: Transcatheter Mitral Valve Replacement (TMVR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
December 2021
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

Exclusion Criteria:

  • Unsuitable anatomy
  • Prohibitively high risk
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jill Trekell (949) 250-2672 jill_trekell@edwards.com
United States
 
 
NCT02718001
2013-05C
Yes
Not Provided
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Robert Guyton, MD Emory University Hospital, Atlanta GA
Principal Investigator: James Hermiller, MD St. Vincent Heart Center, Indianapolis, IN
Edwards Lifesciences
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP