Tricuspid Regurgitation
Conditions
Keywords
Functional, TR, FTR, Transcatheter, Repair, Regurgitation, Degenerative
Brief summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
Interventions
Repair of the tricuspid valve through a transcatheter approach
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
* Severe functional or degenerative TR * Symptomatic despite medical therapy * The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair
Exclusion criteria
* Unsuitable anatomy * Previous tricuspid valve repair or replacement * Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Major Adverse Event (MAE) Rate | 30 days | Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Intraprocedural | Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis |
| Procedural Success | Discharge (2-7 days) | Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis |
| Clinical Success | 30 days | Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusheel K. Kodali, MD
Columbia University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Edwards PASCAL Transcatheter Tricuspid Valve Repair System Tricuspid valve repair with PASCAL implanted via transcatheter procedure | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Edwards PASCAL Transcatheter Tricuspid Valve Repair System |
|---|---|
| Age, Continuous | 77.4 Years STANDARD_DEVIATION 8.96 |
| Body Mass Index | 26.8 Kilogram Per Square Meter STANDARD_DEVIATION 5.97 |
| Clinical Frailty Total Score Mild-to-Moderately Frail | 15 Participants |
| Clinical Frailty Total Score Non-Frail | 48 Participants |
| Clinical Frailty Total Score Severely Frail | 0 Participants |
| EuroScore II | 5.1 % STANDARD_DEVIATION 4.76 |
| Katz Activities of Daily Living Total Score | 5.8 Unit on a scale STANDARD_DEVIATION 0.48 |
| Modified Rankin Scale Moderate disability | 1 Participants |
| Modified Rankin Scale No significant disability despite symptoms | 2 Participants |
| Modified Rankin Scale No symptoms at all | 3 Participants |
| NYHA Class Class I | 1 Participants |
| NYHA Class Class II | 17 Participants |
| NYHA Class Class III | 45 Participants |
| NYHA Class Class IV | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 29 Participants |
| STS Mortality Score (MV Repair) | 7.4 % STANDARD_DEVIATION 4.95 |
| Tobacco Use Current Daily Smoker | 0 Participants |
| Tobacco Use Former Daily Smoker | 26 Participants |
| Tobacco Use Never | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 29 / 65 |
| other Total, other adverse events | 59 / 65 |
| serious Total, serious adverse events | 56 / 65 |
Outcome results
Primary
Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Composite Major Adverse Event (MAE) Rate | 6 Participants |
Secondary
Clinical Success
Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis
Time frame: 30 days
Population: The outcome is reported where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Clinical Success | 43 Participants |
Secondary
Device Success
Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis
Time frame: Intraprocedural
Population: Per device analysis
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Device Success | 90 Device |
Secondary
Procedural Success
Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis
Time frame: Discharge (2-7 days)
Population: The outcome is reported where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Procedural Success | 49 Participants |