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Recruiting NCT04919980

TVMR With the INNOVALVE System Trial - Early Feasibility Study

No phase Interventional Mitral Valve Regurgitation (Degenerative or Functional)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INNOVALVE system.
Who it may be relevant to
Registry conditions: Mitral Valve Regurgitation (Degenerative or Functional). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Study to evaluate the safety and performance of the INNOVALVE system

Detailed description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system

Interventions

  • Device INNOVALVE system
    INNOVALVE system

Primary outcome measures

  • Absence of implant or delivery related serious adverse events at 30 Days [Time frame: 30 days]
Secondary outcome measures (6)
  • Technical success [Time frame: Procedure]
  • Procedural success [Time frame: 30 days]
  • NYHA functional class [Time frame: 30 days, 6, 12 months and annually up to 5 years]
  • Six-minute walk test [Time frame: 30 days, 6, 12 months and annually up to 5 years]
  • Quality of life improvement (KCCQ-12) [Time frame: 30 days, 6, 12 months and annually up to 5 years]
  • Reduction in MR grade [Time frame: 30 days, 6, 12 months and annually up to 5 years]

Eligibility criteria

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Cedars-Sinai — Los Angeles
  • Stanford University — Palo Alto
  • Naples Comprehensive Health — Naples
  • Emory University — Atlanta
  • Piedmont Heart Institute — Atlanta
  • Northwestern — Chicago
  • University of Michigan Hospital and Health Systems — Ann Arbor
  • Mayo Clinic — Rochester
  • … and 12 more centers

Identifiers

NCT: NCT04919980 · 2024-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗