Valvular & structural heart diseaseResearch article
6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement
- Early feasibility study
- single-arm
- independent core laboratory
- independent clinical events committee
- Median follow-up 182 days (Q1-Q3: 171-191 days)
Authors' conclusion
Among patients with significant MR, the AltaValve TMVR system was feasible, safe, and associated with good valve function at 6 months.
Study context
- Population
- Patients with symptomatic mitral regurgitation (MR) unsuitable for surgerymedian age 77 years
- Participants
- 30 patients
- Outcome
- Technical success (no procedural mortality; successful implant delivery and deployment; successful delivery system retrieval; no implant-related emergency surgery or re-intervention)
Main finding
As reported in the abstract
Procedural success
Procedural success
29 of the 30 cases (96.7%; 95% CI: 82.8%-99.9%)
Further findings
Reduction to mild or less MR · 30 days and 6 months
- Achieved in all surviving patients at 30 days; maintained in all but 1 patient at 6 months
Functional class and quality of life
- Significant improvements
Safety
Stroke, new pacemaker implantation, mitral valve reintervention · within 6 months
- No strokes, new pacemaker implantations or mitral valve reinterventions
Original publication
6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement. JACC Cardiovasc Interv. Published 10 November 2025. doi:10.1016/j.jcin.2025.08.040
Summarised from the published abstract; every number is checked against it