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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
Results First Posted : January 6, 2022
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
Device: Edwards FORMA Tricuspid Transcatheter Repair System



Primary Outcome Measures :
  1. Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE [ Time Frame: 30 days ]
    Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention for study device related complications or on the previously implanted study device, and major access site and vascular complications requiring intervention at 30 days.


Secondary Outcome Measures :
  1. Device Success : Count and Percentage of Patients Who Experienced Device Success [ Time Frame: Intraprocedural ]
    Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

  2. Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success [ Time Frame: Discharge (2-8 days) ]
    Device success with evidence of TR reduction as evidenced by a relative reduction in EROA of ≥ 30% from baseline to discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge.

  3. Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success [ Time Frame: 30 days ]
    Procedural success without MAEs at 30 days. (MAEs: cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention and major access site and vascular complications)



Information from the National Library of Medicine

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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

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
Sponsors and Collaborators
Edwards Lifesciences
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Study Protocol: Rev K  [PDF] February 8, 2018
Study Protocol: Rev M  [PDF] February 4, 2019
Statistical Analysis Plan  [PDF] April 1, 2019

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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
Results First Posted: January 6, 2022
Last Update Posted: January 6, 2022
Last Verified: December 2021
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases