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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

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ClinicalTrials.gov Identifier: NCT02471807
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : June 14, 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
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


Contacts
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Contact: TMTT Clinical 949-250-2500 TMTT_Clinical@edwards.com

Locations
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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: Elizabeth Charles    404-686-1249    elizabeth.z.charles@emory.edu   
Principal Investigator: Vasilis Babaliaros, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Craig Konwinski    507-255-6133    konwinski.craig@mayo.edu   
Contact: Amanda Biddle    507-255-6133    Biddle.Amanda@mayo.edu   
Principal Investigator: Mackram Eleid, MD         
Sub-Investigator: Charanjit Rihal, MD         
Sub-Investigator: David Holmes, MD         
Sub-Investigator: Mayra Guerrero, MD         
Sub-Investigator: Samuel Asirvatham, MD         
Sub-Investigator: John Stulak, MD         
Sub-Investigator: Sorin Pislaru, MD         
Sub-Investigator: Vuyisile Nkomo, MD         
Sub-Investigator: Sunil Mankad, 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         
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Jennifer Jordan    484-476-8580    JordanJe@mlhs.org   
Principal Investigator: William Gray, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Linda Bailes, RN    434-982-1058    lgs2m@hscmail.mcc.virginia.edu   
Contact: Jessica Morris    434-982-1058    jlm6uw@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02471807     History of Changes
Other Study ID Numbers: 2014-04
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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