Long-term Survival
Global Cardiology
Janusz Lipiecki, Piotr Kalmucki, Larry E. Miller, Nicolas Durel
July 2026
A single-center extension of the REDUCE FMR trial provides the longest known follow-up for any transcatheter mitral repair therapy.
- Ten-year cardiovascular survival was 66% demonstrating long-term durability and treatment impact in an advanced heart failure population
- Median survival was 5.6 years in an elderly and high-risk FMR population
- Predictors of long-term outcomes included baseline LVEF less than 35% and early heart failure hospitalization
THT 2025 Symposium Presentation
Witte
2025
A multi-center, real-world study of up to 500 patients treated with the Carillon Mitral Contour System as standard of care.
Interim analysis of 228 prospective and retrospective patients with up to 5 years of follow-up for safety and efficacy.
This data confirms results from multiple clinical studies that the Carillon therapy has an excellent safety profile, sustained clinical and mechanistic efficacy benefits, and is associated with improved long-term term survival.
ESC Heart Failure
doi: 10.1002/ehf2.12955
October 2020
- Patients implanted with the Carillon Mitral Contour System were evaluated for long‐term follow‐up post‐procedure up to 7.5 years.
- Patients experienced a clinically significant reduction in heart failure hospitalizations and symptom improvement post procedure which was sustained through the 6+ year follow-up period.
- Long-term mortality was 40% at 6 years, which compares favorably to several prior studies that have evaluated medically managed patients with FMR.
Patients treated with the Carillon device continue to show sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status 6+ years post procedure. All patients at 6 year follow-up had MR 2+ or less with over half having MR 1+ or trace, and LVEDV was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL (p=0.03).
Department of Cardiology, Frankfurt University Hospital, Frankfurt, Germany
doi: 10.5114/amsad.2020.97160
June 2020
- First study to directly compare patients treated with either Carillon (n=37) or MitraClip (n=137).
- MR grade was significantly reduced (p<0.001) in both groups after procedure.
- MR grade remained reduced in Carillon patients at 2 years (n=9).
- Survival was assessed up to 5 years.
- Median survival in the Carillon group was 3.92 years vs 1.66 years in the MitraClip group (p = 0.01).
- Numerous baseline factors may contribute to the difference in survival benefit observed.
- Pulmonary artery pressure was reduced in both groups after intervention (p<0.05), however, continued decrease at later follow up was observed only in the Carillon group.
This analysis brings new insights into the long-term role of the Carillon Mitral Contour system for the treatment of symptomatic congestive heart failure with functional mitral regurgitation.
A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies who had symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction were assessed as part of the analysis. For all patients, echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years.
- Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling.
- The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years and 56.2% at 4 and 5 years of follow-up.
- Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up.
- Three-year mortality rate compared to published outcomes of COAPT and guideline directed medical therapy (GDMT), using matched patient populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT.
Cardiovascular Revascularization Medicine
Lipiecki et al.
February 2020
This analysis brings new insights into the long-term role of the Carillon Mitral Contour system for the treatment of symptomatic congestive heart failure with functional mitral regurgitation.
A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies who had symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction were assessed as part of the analysis. For all patients, echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years.
- Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling.
- The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years and 56.2% at 4 and 5 years of follow-up.
- Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up.
- Three-year mortality rate compared to published outcomes of COAPT and guideline directed medical therapy (GDMT), using matched patient populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT.
