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
This trial does not accept healthy volunteersQualifiers
Clinically significant, symptomatic mitral regurgitation
High risk for open-heart surgery
Meets anatomical criteria
Disqualifiers
Unsuitable anatomy
Patient is inoperable
EF<25%
Trial design
Design model
Single group
Treatments tested in this trial
INNOVALVE system
DeviceINNOVALVE system
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Absence of implant or delivery related serious adverse events at 30 Days
Absence of implant or delivery related serious adverse events
Time frame
30 daysSecondary outcomes
1
Technical success
Time frame
Procedure2
Procedural success
Time frame
30 days3
NYHA functional class
Time frame
30 days, 6, 12 months and annually up to 5 years4
Six-minute walk test
Time frame
30 days, 6, 12 months and annually up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov