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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

Tracking Information
First Submitted Date  ICMJE June 11, 2015
First Posted Date  ICMJE June 15, 2015
Results First Submitted Date  ICMJE October 1, 2021
Results First Posted Date  ICMJE January 6, 2022
Last Update Posted Date January 6, 2022
Study Start Date  ICMJE December 2015
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
Procedural Success [ Time Frame: 30 days ]
Device success and freedom from device or procedure related SAE's at 30 days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2021)
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Official Title  ICMJE Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Valve Regurgitation
Intervention  ICMJE Device: Edwards FORMA Tricuspid Transcatheter Repair System
Study Arms  ICMJE Experimental: Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
Intervention: Device: Edwards FORMA Tricuspid Transcatheter Repair System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 9, 2021)
34
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2015)
15
Estimated Study Completion Date  ICMJE January 2023
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02471807
Other Study ID Numbers  ICMJE 2014-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Edwards Lifesciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Edwards Lifesciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Edwards Lifesciences
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP