Tricuspid Valve Insufficiency
Conditions
Brief summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
Detailed description
The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.
Interventions
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
DEVICEEdwards PASCAL Precision Transcatheter Valve Repair System
The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team 2. TR grade ≥3+ (5 grade classification) 3. Patient is eligible to receive the PASCAL device per the current approved indications for use
Exclusion criteria
1. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement 2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation 3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator 4. Any patient considered to be part of a vulnerable population
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with major adverse events (MAE rates) | 30 days | The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days |
| Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography | Discharge: defined as discharge or 7 days post-procedure, whichever comes first | Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume overload assessed by serial measurements | baseline, 30 days, 6 months, 12 months, annually up to 5 years | Patient edema questionnaire |
| Functional class, functional status, and Quality of life as assessed | baseline, 30 days, 6 months, 12 months, annually up to 5 years | NYHA classification (I-IV) grade |
Countries
Germany, Greece, Italy, Switzerland
Contacts
PRINCIPAL_INVESTIGATORStephan Baldus, Prof. Dr.
Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
Outcome results
None listed