Published February 15, 2026. The EMBRACE Registry has been announced in Europe as a post market registry for catheter based mitral valve replacement. Sponsored by HighLife SAS, the study is not yet recruiting. This development signals a structured data collection effort to monitor safety and performance of TMVR in the real world. Clinicians, regulators, and device manufacturers should watch for updates as recruitment begins and data are reported.
What is the EMBRACE Registry?
The EMBRACE Registry is described as a European post market registry for catheter based mitral valve replacement. It is sponsored by HighLife SAS and is currently Not yet recruiting. The registry aims to collect real world data to inform safety and performance of TMVR in patients with mitral regurgitation.
What device and condition does it address?
The registry focuses on catheter based replacement of the mitral valve in patients with mitral regurgitation using transcatheter mitral valve replacement technology. This approach represents a shift from surgical repair to percutaneous intervention in appropriate patient populations.
What regulatory context applies to this registry?
As a European post market data collection effort, the EMBRACE Registry is positioned to support ongoing safety and performance monitoring of TMVR in a real world setting. While the source text does not specify regulatory requirements, registries of this type are commonly used to gather evidence to inform regulatory decisions and clinical practice. Regulators rely on post market evidence to identify rare adverse events, assess durability, and confirm real world performance across diverse centers.
What should regulators and sponsors monitor?
Expected data include device performance outcomes, safety events, and overall usability in diverse patient populations. Access to such data is anticipated to help evaluate long term benefits and risks associated with catheter based mitral valve replacement.
Who should care about the EMBRACE Registry?
Physicians performing TMVR, hospital systems, and surgical teams will be primary users of registry results once recruitment progresses. Regulators will review data to assess safety signals and performance trends. Sponsor HighLife SAS maintains responsibility for study oversight, while data access may be governed by registry policies and data sharing agreements. The registry can influence patient pathways by informing device selection and operator training programs.
What does this mean for clinicians and patients?
Clinicians may gain real world insights into device performance and patient outcomes across European centers. Patients stand to benefit from transparency about safety and effectiveness as data become available through post market surveillance. The existence of a European registry underscores the ongoing commitment to monitoring TMVR in routine practice and to improving evidence based care for mitral regurgitation.
- 1. What is the EMBRACE Registry?
The EMBRACE Registry is a European post market registry for catheter based mitral valve replacement sponsored by HighLife SAS. Recruitment is not yet underway.
- 2. Who funds and oversees the registry?
HighLife SAS is the sponsor listed in the source text. Oversight details are described in the registry documentation and on ClinicalTrials.gov.
- 3. Where can I find more information?
Full details are available on ClinicalTrials.gov at NCT07409285 with the term medical device in the search query.
Conclusion
The EMBRACE Registry represents a Europe wide effort to collect real world data on catheter based mitral valve replacement. Stakeholders should monitor recruitment progress and data updates through the ClinicalTrials.gov record NCT07409285 to inform regulatory and clinical decision making. This approach aligns with the ongoing emphasis on post market surveillance for medical devices used in the treatment of mitral regurgitation.
This information is intended for professionals and is not legal advice. It reflects interpretation of the source text and does not replace regulatory guidance. For formal regulatory opinions consult the relevant authorities.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07409285?term=medical+device