Tricuspid Valve Regurgitation
Conditions
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.
Interventions
DEVICEEdwards FORMA Tricuspid Transcatheter Repair System
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE | 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
| Measure | Time frame | Description |
|---|---|---|
| Device Success : Count and Percentage of Patients Who Experienced Device Success | 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 | 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 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Explant | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Edwards FORMA Tricuspid Transcatheter Repair System | — |
|---|---|---|
| Age, Continuous | 77 years STANDARD_DEVIATION 8.2 | — |
| BMI | 26.2 kg/m^2 STANDARD_DEVIATION 4.2 | — |
| New York Heart Association Class (NYHA) Class I | 0 Participants | — |
| New York Heart Association Class (NYHA) Class II | 6 Participants | — |
| New York Heart Association Class (NYHA) Class III | 20 Participants | — |
| New York Heart Association Class (NYHA) Class IV | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| The European System for Cardiac Operative Risk Evaluation: EuroScore II | 7.5 score STANDARD_DEVIATION 5.23 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 34 |
| other Total, other adverse events | 32 / 34 |
| serious Total, serious adverse events | 33 / 34 |
Outcome results
Primary
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.
Time frame: 30 days
Population: The intention-to-treat (ITT) population includes all patients who signed informed consent, met eligibility criteria, and in whom the study procedure has been attempted (i.e. at least skin incision to introduce the FORMA System).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System | Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE | 10 Participants |
Secondary
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)
Time frame: 30 days
Population: The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System | Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success | 11 Participants |
Secondary
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.
Time frame: Intraprocedural
Population: The intention-to-treat (ITT) population includes all patients who signed informed consent, met eligibility criteria, and in whom the study procedure has been attempted (i.e. at least skin incision to introduce the FORMA System).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System | Device Success : Count and Percentage of Patients Who Experienced Device Success | 32 Participants |
Secondary
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.
Time frame: Discharge (2-8 days)
Population: The as-treated population is a subset of ITT population and includes all patients in whom the study device is implanted and remains in position at the time of the patient's exit from the procedure room.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System | Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success | 12 Participants |