Back to resultsEarly Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Primary Purpose
Tricuspid Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards FORMA Tricuspid Transcatheter Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Valve Regurgitation
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical Center
- Emory University Hospital
- Mayo Clinic
- Morristown Medical Center
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Edwards FORMA Tricuspid Transcatheter Repair System
Arm Description
Edwards FORMA Tricuspid Transcatheter Repair System
Outcomes
Primary Outcome Measures
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
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
Device Success : Count and Percentage of Patients Who Experienced Device Success
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
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02471807
Brief Title
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Official Title
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
January 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Edwards FORMA Tricuspid Transcatheter Repair System
Arm Type
Experimental
Arm Description
Edwards FORMA Tricuspid Transcatheter Repair System
Intervention Type
Device
Intervention Name(s)
Edwards FORMA Tricuspid Transcatheter Repair System
Primary Outcome Measure Information:
Title
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Device Success : Count and Percentage of Patients Who Experienced Device Success
Description
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.
Time Frame
Intraprocedural
Title
Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success
Description
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.
Time Frame
Discharge (2-8 days)
Title
Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
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