Cardiovalve proposes a non-invasive, simply deployed, transferal expandable bioprosthetic valve for eliminating tricuspid regurgitation in patients who are not suitable for open heart surgery. Cardiovalve targets an unmet clinical need. TARGET study is a prospective, single arm, open label, multi center, clinical study aimed at demonstrating safety and performance of the minimally invasive transcatheter Cardiovalve TR replacement system to reduce Tricuspid regurgitation.
Sponsor
Study objectives
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system.
Primary endpoints
- Primary efficacy endpoint for this study is the percentage of successful implantation of the valve with ≤2+ Tricuspid Regurgitation at 30 days.
- Primary safety will be analyzed as a composite endpoint of Major Adverse Events (per Tricuspid Valve Academic Research Consortium - TVARC definitions).
CERC Services
- CEC and DSMB activities
- EDC and data management
- Final study report
- Health economics analysis
- Monitoring activities
- Project management
- Regulatory submissions
- Safety reporting
- Sites' contract management
- Statistical Activities
- Study documents draft and review
Countries
5 countries: Canada, Germany, Spain, Italy, United Kingdom (CERC is in charge of UK).
Number of investigational sites
50 sites (5 sites in UK)
