TVMR With the INNOVALVE System Trial - Early Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
Study to evaluate the safety and performance of the INNOVALVE system
Eligibility criteria
Qualifiers
Clinically significant, symptomatic mitral regurgitation
High risk for open-heart surgery
Meets anatomical criteria
Disqualifiers
Unsuitable anatomy
Patient is inoperable
EF<25%
Trial design
Treatments tested in this trial
- INNOVALVE system
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov