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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471807
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Tricuspid Valve Regurgitation Device: Edwards FORMA Tricuspid Transcatheter Repair System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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
Study Start Date : December 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
 Device: Edwards FORMA Tricuspid Transcatheter Repair System


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Event Rate [ Time Frame: 30 days ]
    Rates of major adverse events at 30 days


Secondary Outcome Measures :
  1. Device Success [ Time Frame: Intraprocedural ]
    Rate of device deployment as intended

  2. Procedure Success [ Time Frame: Discharge (2-8 days) ]
    Rate of device success and subsequent reduction of tricuspid regurgitation

  3. Clinical Success [ Time Frame: 30 days ]
    Rate of procedural success without major adverse events at 30 days


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

Inclusion Criteria:

  1. ≥ 18 years old
  2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team

Exclusion Criteria:

  1. Tricuspid valve/right heart anatomy not suitable for the study device
  2. Moderate or greater tricuspid valve stenosis
  3. Severe RV dysfunction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471807


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02471807    
Other Study ID Numbers: 2014-04
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases