Health TrialsbyHealthPanel

TVMR With the INNOVALVE System Trial - Early Feasibility Study

ConditionMitral Valve Regurgitation (Degenerative or Functional)
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 volunteers

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

Design model

Single group

Treatments tested in this trial

  • INNOVALVE system

    Device

    INNOVALVE system

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serious adverse events (SAE) through 30 days post-procedure

Serious adverse events (SAE) through 30 days post-procedure

Time frame
30 days

Secondary outcomes

1

Technical success

Time frame
Procedure
2

Procedural success

Time frame
30 days
3

NYHA functional class

Time frame
30 days, 6, 12 months and annually up to 5 years
4

Six-minute walk test

Time frame
30 days, 6, 12 months and annually up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Edwards Lifesciences

Lead sponsor

Source ClinicalTrials.gov
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