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NCT Number: NCT02471807

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

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.

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Tricuspid valve/right heart anatomy not suitable for the study device
  • Moderate or greater tricuspid valve stenosis
  • Severe RV dysfunction

Treatment and study plan

Edwards FORMA Tricuspid Transcatheter Repair System

Device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2023
First posted
Jun 15, 2015
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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