Valvular & structural heart disease

6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study

JACC Cardiovasc IntervPublished Early feasibility study

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)
Methodological detailssingle-arm, independent core laboratory, independent clinical events committee, Median follow-up 182 days (Q1-Q3: 171-191 days)
  • Single-arm
  • Independent core laboratory
  • Independent clinical events committee
  • Median follow-up 182 days (Q1-Q3: 171-191 days)

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: An Early Feasibility Study. JACC Cardiovasc Interv. Published 10 November 2025. doi:10.1016/j.jcin.2025.08.040

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