NCT05688514

Brief Summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

5 days

First QC Date

December 22, 2022

Last Update Submit

April 18, 2025

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Outcome Measures

Primary Outcomes (1)

  • Absence of implant or delivery related serious adverse events at 30 days

    Absence of implant or delivery related serious adverse events

    30 days

Secondary Outcomes (6)

  • Technical success

    Procedure

  • Procedural success

    30 days

  • NYHA functional class

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

  • Six-minute walk test

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

  • Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire

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

  • +1 more secondary outcomes

Study Arms (1)

Innovalve TMVR System

EXPERIMENTAL

MV replacement with Innovalve MR system

Device: Innovalve MR system

Interventions

Innovalve MR systemDEVICE

Innovalve MR system

Innovalve TMVR System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

You may not qualify if:

  • Unsuitable anatomy
  • Patient is inoperable
  • EF\<25%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 18, 2023

Study Start

October 1, 2021

Primary Completion

October 6, 2021

Study Completion

April 1, 2025

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)