Valvular & structural heart diseaseCohort study
Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System
- Registry cohort study
- STS/ACC TVT Registry
- site-assessed outcomes
All outcomes, including echocardiographic assessments, site-assessed
Authors' conclusion
Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.
Study context
- Population
- US patients with degenerative mitral regurgitation (DMR) treated with the PASCAL Precision system (commercial experience)
- Participants
- 1,995 patients
Main finding
As reported in the abstract
Device implantation and MR reduction · 30 days
Device successfully implanted
97.7%
≤moderate MR at 30 days
94.2%
≤mild MR at 30 days
72.6%
MR reduction vs baseline
P < 0.001
Observational data: associations, not effects.
Safety
Reintervention, single-leaflet device attachment, mortality and HF readmission · 30 days
- Mitral valve reintervention
- 0.4%
- Single-leaflet device attachment
- 0.5%
- All-cause mortality
- 2.2%
- CV mortality
- 1.2%
- HF readmission
- 2.6%
Original publication
Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System. JACC Cardiovasc Interv. Published 25 August 2025. doi:10.1016/j.jcin.2025.07.019
Summarised from the published abstract; every number is checked against it