Valvular & structural heart diseaseResearch article

One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study

Circ Cardiovasc IntervPublished

  • multicenter European postmarket clinical follow-up study

Authors' conclusion

One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.

Study context

Population
Patients with functional mitral regurgitation (atrial functional mitral regurgitation (AFMR) or ventricular functional mitral regurgitation (VFMR)) undergoing mitral transcatheter edge-to-edge repair with the PASCAL systemfrom the first 600 enrolled in the MiCLASP study · AFMR 52 · VFMR 243
Participants
295 patients
Comparison
AFMR vs VFMR
  • AFMRn = 52
  • VFMRn = 243

Main finding

As reported in the abstract

Procedural success

Further findings

Procedure duration

Freedom from all-cause mortality or heart failure hospitalizations (Kaplan-Meier estimate) · One-year

Echocardiographic, functional and quality-of-life outcomes · One-year

mitral regurgitation ≤1+

mean transmitral gradient AFMR 3.5 mm Hg · VFMR 3.1 mm Hg

left ventricular end-diastolic volume AFMR −12.9% · VFMR −16.4%

left atrial volume AFMR −9.6% · VFMR −10.9%

New York Heart Association class I/II

Kansas City Cardiomyopathy Questionnaire Overall Summary score AFMR +18.0 points · VFMR +11.6 points

Baseline characteristics

age AFMR 79.7±6.67 years · VFMR 74.6±10.30 years

female

hypertension

atrial fibrillation

NT-proBNP AFMR 1562.0 [790.0-2286.0] · VFMR 3350.0 [1720.0-6564.0]

mitral regurgitation ≥3+

  • Procedure duration: P =0.044
  • Freedom from all-cause mortality or heart failure hospitalizations (Kaplan-Meier estimate): P =0.267
  • Echocardiographic, functional and quality-of-life outcomes: all P <0.05 from baseline
  • Baseline characteristics: age, sex, hypertension, atrial fibrillation: all P <0.05
  • Baseline characteristics: NT-proBNP P <0.001
  • Baseline characteristics: mitral regurgitation ≥3+ P <0.001

Original publication

One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study. Circ Cardiovasc Interv. Published 25 August 2026. doi:10.1161/circinterventions.126.016563

Summarised from the published abstract; every number is checked against it