Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

(TIARA-I Trial)

Not currently recruiting at 11 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to replace a faulty mitral valve without open-heart surgery. It evaluates the safety and effectiveness of the Neovasc Tiara Mitral Valve System, a transcatheter mitral valve replacement, for individuals with severe mitral valve regurgitation. This condition occurs when the heart’s mitral valve doesn’t close tightly, causing blood to flow backward. The trial seeks participants with severe symptoms, such as shortness of breath or fatigue, who are at high risk for traditional surgery. Participants should have heart failure symptoms that significantly affect their daily activities. This study suits those whose condition makes them unsuitable for regular heart surgery. As an unphased trial, it offers a unique opportunity for patients to access innovative treatment options that may significantly improve their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Neovasc Tiara Mitral Valve System is safe for mitral valve regurgitation?

Research has shown that the Neovasc Tiara Mitral Valve System holds promise for safety. Studies have found that the valve implantation procedure is straightforward, consistently performed, and safe. No reports of mechanical problems, such as frame breaks or blood clots, have occurred during its use in clinical settings.

Patients have demonstrated excellent heart function post-procedure, with no major issues before hospital discharge. These findings suggest that the treatment is generally well-tolerated, though further information may be needed to fully understand its long-term safety.

Overall, the initial results are encouraging for those considering participation in trials with the Neovasc Tiara Mitral Valve System. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical options for mitral valve regurgitation, like open-heart surgery for valve repair or replacement, the Neovasc Tiara™ Mitral Valve System offers a minimally invasive alternative. This treatment is unique because it uses a transcatheter approach to replace the mitral valve, which means it can be delivered to the heart through a small incision, reducing the need for more invasive surgery. Researchers are particularly excited about its transapical delivery system, which allows for precise placement of the valve, potentially leading to better outcomes and quicker recovery times for patients. This innovation could be a game-changer, especially for patients who are high-risk surgical candidates.

What evidence suggests that the Neovasc Tiara Mitral Valve System is effective for mitral valve regurgitation?

Research has shown that the Neovasc Tiara Mitral Valve System holds promise for treating mitral valve regurgitation, a condition where the heart's mitral valve fails to close properly, causing blood to leak backward. In early studies, doctors successfully implanted the valve in 96% of patients, with no deaths during the procedure. One study found that after one year, 86% of patients remained alive. In most cases, the valve stayed in place and effectively stopped the backward flow of blood. These results suggest that the Tiara valve could be a good treatment option for people with this heart condition. ^{2 3 4 6 7}

Who Is on the Research Team?

Anson Cheung, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02276547

Early Feasibility Study of the Neovasc Tiara™ Mitral Valve ... 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 ...

2. clinicaltrial.be clinicaltrial.be/en/details/11558?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Early Feasibility Study of the Neovasc Tiara™ Mitral Valv... This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9783604/

Outcomes after Transcatheter Mitral Valve Implantation The survival rate at the 1-year follow-up in VIV, VIR and VMAC were 86%, 82% and 57%, respectively. The predictor factor for the LVOT ...

4. jacc.org jacc.org/doi/10.1016/j.jcin.2020.12.038

Transcatheter Mitral Valve Replacement: An Update on ... Experience in the first 100 patients revealed promising results, with successful implantation in 96% and no procedural mortality or emergency ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/the-tiara-transcatheter-mitral-valve-implantation-system

The Tiara transcatheter mitral valve implantation system In seven of the eight cases, Tiara was successfully implanted as intended, resulting in a stable and well-anchored prosthetic valve with complete resolution of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6288213/

Early experience of TIARA transcatheter mitral valve ... The transventricular implant procedure is straight-forward, reproducible and safe. Correction of MR is complete with excellent hemodynamics. Ongoing ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03039855

Tiara™ Transcatheter Mitral Valve Replacement Study To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System. Detailed Description.