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TVMR With the INNOVALVE System Trial - Early Feasibility Study

NCT04919980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-01-30

No results posted yet for this study

Summary

Study to evaluate the safety and performance of the INNOVALVE system

Conditions

  • Mitral Valve Regurgitation (Degenerative or Functional)

Interventions

DEVICE

INNOVALVE system

INNOVALVE system

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Chet Rihal · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-07-01
Completion
2031-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04919980 on ClinicalTrials.gov