NCT05263375

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

February 21, 2022

Last Update Submit

July 18, 2024

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Outcome Measures

Primary Outcomes (1)

  • Number of patients with implant or delivery related serious adverse events at 30 days

    Number of patients with implant or delivery related serious adverse events at 30 days

    30 days

Study Arms (1)

MV replacement with Innovalve TMVR system

EXPERIMENTAL

MV replacement with Innovalve TMVR system

Device: Innovalve TMVR system

Interventions

Innovalve TMVR systemDEVICE

Innovalve TMVR system

MV replacement with 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 \<30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases
0

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

February 21, 2022

First Posted

March 2, 2022

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07