Feasibility Study of the Edwards Self-Expanding Mitral THV System: Edwards Self-Expanding Mitral Transcatheter Heart Valve with Transapical Delivery System and Accessories

Feasibility Study of the Edwards Self-Expanding Mitral THV System: Edwards Self-Expanding Mitral Transcatheter Heart Valve with Transapical Delivery System and Accessories - Not Applicable

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007725

Enrollment

Registered

2015-01-26

Start date

2014-08-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with clinically significant, symptomatic mitral regurgitation requiring either mitral valve repair or replacement who are at high surgical risk as assessed by the Heart Team. I34.0

Interventions

Group 1: Edwards Self-Expanding Mitral THV System: Edwards Self-Expanding Mitral Transcatheter Heart Valve with Transapical Delivery System and Accessories

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Signed and dated EC approved study consent form prior to study related procedures 2. Sixty years of age or older 3. Clinically significant, symptomatic mitral regurgitation 4. Willing to attend study follow-up assessments for up to 5 years

Exclusion criteria

Exclusion criteria: Mitral valve anatomy not suitable for the study device

Design outcomes

Primary

Measure	Time frame
Freedom from death at 30 days from the implant procedure	—

Secondary

Measure	Time frame
Freedom from heart failure hospitalization at 1 year from the implant procedure	—

Countries

Germany

Contacts

Public ContactJill Trekell

Edwards Lifesciences

jill_trekell@edwards.com1 949-250-2672

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026