NCT05010746

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
39mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress53%
Jan 2023Oct 2029

First Submitted

Initial submission to the registry

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2024

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2029

Expected
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

August 11, 2021

Last Update Submit

June 23, 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 at 30 days

    30 days

Secondary Outcomes (11)

  • Technical Success

    Procedure

  • Procedural Success

    30 days

  • Device Success

    30 days, 3, 6, 12 months and annually up to 5 years

  • Patient Success

    1 year

  • Change in NYHA Class

    30 days, 3, 6, 12 months and annually up to 5 years

  • +6 more secondary outcomes

Study Arms (1)

MV replacement with Innovalve MR system

EXPERIMENTAL

MV replacement with Innovalve MR system

Device: Innovalve TMVR system

Interventions

Innovalve TMVR systemDEVICE

Innovalve TMVR system

MV replacement with Innovalve MR 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

Study Sites (1)

Humanitas

Milan, Italy

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Antonio Colombo, Prof

    Humanitas IRCCS

    PRINCIPAL INVESTIGATOR

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

August 11, 2021

First Posted

August 18, 2021

Study Start

January 24, 2023

Primary Completion

May 4, 2024

Study Completion (Estimated)

October 4, 2029

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)