An interventional study of Edwards FORMA Tricuspid Transcatheter Repair System in Tricuspid Valve Regurgitation, sponsored by Edwards Lifesciences. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Edwards Lifesciences · Not applicable, Interventional, and Treatment
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.
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 118 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Edwards FORMA Tricuspid Transcatheter Repair System
Device: Edwards FORMA Tricuspid Transcatheter Repair System
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
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
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)
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
| Milestone | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Started | 34 |
| Completed | 12 |
| Not completed | 22 |
| Withdrew: Death | 14 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Explant | 5 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE | 10 |
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.
| Participants | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Device Success : Count and Percentage of Patients Who Experienced Device Success | 32 |
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.
| Participants | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success | 12 |
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)
| Participants | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success | 11 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Edwards FORMA Tricuspid Transcatheter Repair System | 14/34 (41.2%) | 33/34 (97.1%) | 32/34 (94.1%) |
| Event | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Cardiac failureCardiac disorders | 13/34 |
| AnaemiaBlood and lymphatic system disorders | 7/34 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 4/34 |
| HypotensionVascular disorders | 4/34 |
| Cardiac arrestCardiac disorders | 3/34 |
| Cardiac failure acuteCardiac disorders | 3/34 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 3/34 |
| DeathGeneral disorders | 3/34 |
| Acute kidney injuryRenal and urinary disorders | 3/34 |
| Renal failureRenal and urinary disorders | 3/34 |
| Event | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 7/34 |
| Cardiac failureCardiac disorders | 6/34 |
| Renal failureRenal and urinary disorders | 6/34 |
| Ventricular tachycardiaCardiac disorders | 4/34 |
| Urinary retentionRenal and urinary disorders | 4/34 |
| HypotensionVascular disorders | 4/34 |
| AscitesCardiac disorders | 3/34 |
| Bundle branch block rightCardiac disorders | 3/34 |
| Pericardial effusionCardiac disorders | 3/34 |
| Acute kidney injuryRenal and urinary disorders | 3/34 |
| Age, Continuous(years) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Mean | 77 ± 8.20 |
| Sex: Female, Male(Participants) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Female | 22 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|
| BMI(kg/m^2) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Mean | 26.2 ± 4.20 |
| New York Heart Association Class (NYHA)(Participants) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Class I | 0 |
| Class II | 6 |
| Class III | 20 |
| Class IV | 8 |
| The European System for Cardiac Operative Risk Evaluation: EuroScore II(score) | Edwards FORMA Tricuspid Transcatheter Repair System |
|---|---|
| Mean | 7.5 ± 5.23 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tricuspid Valve Insufficiency→
Edwards Lifesciences