TCT 2025 – Dr Nadira Hamid (Minneapolis Heart Institute, US), interventional echocardiographer sits down with ENCIRCLE's (Edwards Lifesciences) Principal Investigator, Dr David V Daniels (California Pacific Medical Center, US) to have a deep dive into the latest data with SAPIEN M3.

The ENCIRCLE trial (NCT04153292) is a prospective, multicentre, single-arm study evaluating the safety and effectiveness of the SAPIEN M3 transcatheter mitral valve replacement (TMVR) system in patients with symptomatic ≥3+ mitral regurgitation who are unsuitable for surgery or other transcatheter options.

With 900 patients enrolled, the study assesses outcomes following transseptal TMVR using the dedicated SAPIEN M3 valve and dock system, offering new insights into a potential treatment pathway for high-risk MR patients.

The composite primary endpoint (all-cause mortality or HF rehospitalization at 1 year) was 25.2% versus the pre-specified 45% performance goal; all-cause mortality and HF rehospitalization were 13.9% and 16.7%, respectively. Over 95% achieved MR ≤1+ at 30 days and 1 year, with TMVR showing a safety profile comparable to TEER and sustained improvements in symptoms and quality of life.

Recorded on-site at TCT Conference in San Francisco, 2025.
Editor: Mirjam Boros & Jordan Rance
Video Specialist: Tom Green & Mike Knight

Support: This is an independent interview produced by Transcatheter Academy.