Tricuspid Regurgitation
Conditions
Keywords
Tricuspid valve, Heart valve, Cardiovascular disease
Brief summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Detailed description
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
Interventions
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Sponsors
Cardiovalve Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single arm, open label, multi center
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Functional TR ≥3+ * Symptomatic, NYHA Class II-IVa * Patient approved by the Subject Screening Committee
Exclusion criteria
* Cardiac anatomy deemed not suitable for the Cardiovalve TR system * Hemodynamic instability * Severe right ventricular failure * Refractory heart failure requiring advanced intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device or procedure-related adverse events | 30 days | Freedom from device or procedure-related adverse events |
| Reduction in TR grade | 30 days | Reduction in TR in comparison to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test | 30 days, 6 months, 12 months, annual for five years | Change in Six minute walk distance from Baseline |
| KCCQ | 30 days, 6 months, 12 months, annual for five years | Change in health status from Baseline |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORGeorg Nickenig, Dr
Bonn Clinic
Outcome results
None listed