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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02471807
First received: June 11, 2015
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Condition Intervention
Tricuspid Valve Regurgitation Device: Edwards FORMA Tricuspid Transcatheter Repair System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: 30 days ]
    Device success and freedom from device or procedure related SAE's at 30 days.


Secondary Outcome Measures:
  • Re-hospitalization rates for the underlying condition (Heart Failure) [ Time Frame: 6-months, 1-Year ]
    Re-hospitalization rates for the underlying condition (Heart Failure)

  • Re-intervention rates for the underlying condition (Tricuspid Regurgitation) [ Time Frame: 6-months, 1-Year ]
    Re-intervention rates for the underlying condition (Tricuspid Regurgitation)

  • Change in NYHA Class from baseline [ Time Frame: 6-months, 1-Year ]
    Change in NYHA Class from baseline

  • Change in 6 minute walk test distance (meters) from baseline [ Time Frame: 6-months, 1-Year ]
    Change in 6 minute walk test distance (meters) from baseline

  • Change in Quality of Life as assessed by the SF-12 and KCCQ questionnaires from baseline [ Time Frame: 6-months, 1-Year ]
    Change in Quality of Life as assessed by the SF-12 and KCCQ questionnaires from baseline


Estimated Enrollment: 30
Study Start Date: December 2015
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
Device: Edwards FORMA Tricuspid Transcatheter Repair System

Detailed Description:

The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinically significant, symptomatic (NYHA Functional Class II or greater) functional or secondary, tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
  2. NYHA Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
  3. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device

Exclusion Criteria:See Protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02471807

Contacts
Contact: Esther Gerteis +41 79 601 53 18 Esther_Gerteis@edwards.com
Contact: Bertha Torres 949 250-2321 bertha_torres@edwards.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Raj Makkar, MD    310-423-3977    Raj.Makkar@cshs.org   
Contact: Mitch Gheorghiu    310-423-6152    Mitch.Gheorghiu@cshs.org   
Principal Investigator: Rajendra Makkar, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Lauren Wheeler    404-712-0131    lmwheeler@emory.edu   
Contact: Lisa Warren    404-912-9554    lisa.warren@emory.edu   
Principal Investigator: Vasilis Babaliaros, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Desirae Howe-Clayton, RN    507-538-3529    howe.desirae@mayo.edu   
Principal Investigator: Mackram Eleid, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Christine Ciprich, RN    973-971-7541    Christine.Ciprich@atlantichealth.org   
Principal Investigator: John M Brown, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton    212-342-1820    keb2114@cumc.columbia.edu   
Contact: Alex Kantor    212-305-4786    ak3697@cumc.columbia.edu   
Principal Investigator: Susheel K Kodali, MD         
Sponsors and Collaborators
Edwards Lifesciences
  More Information

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02471807     History of Changes
Other Study ID Numbers: 2014-04
Study First Received: June 11, 2015
Last Updated: March 9, 2017

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017