Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

(TIARA-I Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shockwave Medical, Inc.

Disqualifiers: Operable DMR, Frailty, Unsuitable cardiac structure

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Procedure day

27 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Research Team

Anson Cheung, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

This trial is for individuals with severe symptomatic mitral valve regurgitation who are at high risk for open heart surgery and have advanced heart failure (NYHA Class III or IV). It's not suitable for those who can undergo regular valve surgery, are extremely frail, listed for a cardiac transplant, or have unsuitable cardiac anatomy.

Inclusion Criteria

I have severe symptoms from mitral valve leakage.

I am considered at high risk for traditional heart valve surgery.

I have severe heart failure.

Exclusion Criteria

My heart condition is considered operable by the medical team.

My heart's structure is not suitable for the study.

I am considered too frail for surgery or am waiting for a heart transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcatheter mitral valve replacement with the Neovasc Tiara Mitral Transcatheter Heart Valve

Procedure day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, including freedom from all-cause mortality and major adverse events

30 days

1 visit (in-person)

Extended Follow-up

Participants are monitored for clinical performance and device success, including echocardiographic assessments and heart failure progression

Annually for five years

Treatment Details

Interventions

• Neovasc Tiara™ Mitral Valve System

Trial Overview The study is testing the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve along with its delivery system. This new method aims to replace the damaged mitral valve through a less invasive procedure than traditional open-heart surgery.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system

Who Is Running the Clinical Trial?

Shockwave Medical, Inc.

Lead Sponsor

Trials

38

Recruited

10,200+

Neovasc Inc.

Lead Sponsor

Trials

8

Recruited

1,400+