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Recruiting

NCT Number: NCT04919980

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Study to evaluate the safety and performance of the INNOVALVE system

Recruiting

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Key information

Conditions

Mitral Valve Regurgitation (Degenerative or Functional) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai, Los Angeles, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

INNOVALVE system

Device

INNOVALVE system

Primary outcomes

  1. Absence of implant or delivery related serious adverse events at 30 Days

    Time frame: 30 days

    Absence of implant or delivery related serious adverse events

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

  5. Quality of life improvement (KCCQ-12)

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

  6. Reduction in MR grade

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

Study contacts

Contact information is provided by the study sponsor or research team.

TMTT Clinical

CONTACT

[email protected]

(949) 250-2500

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: TWIST-EFS

Important dates

Study start
2022
Primary completion
2026
Study completion
2031
First posted
Jun 9, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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