RecruitingNot Applicable

TVMR With the INNOVALVE System Trial - Early Feasibility Study

United States65 participantsStarted 2022-09-01

Plain-language summary

Study to evaluate the safety and performance of the INNOVALVE system

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria Exclusion Criteria: * Unsuitable anatomy * Patient is inoperable * EF\<25%

What they're measuring

Absence of implant or delivery related serious adverse events at 30 Days

Timeframe: 30 days

Trial details

NCT IDNCT04919980

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

TMTT Clinical

(949) 250-2500 TMTT_Clinical@edwards.com

View on ClinicalTrials.gov More Mitral Valve Regurgitation (Degenerative or Functional) trials