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Mitral Valve Replacement Device

Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation (TIARA-I Trial)

N/A

Waitlist Available

Research Sponsored by Neovasc Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe symptomatic mitral regurgitation (Stage D)

High surgical risk for open mitral valve surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at one year

Awards & highlights

TIARA-I Trial Summary

This trial is testing a new mitral valve replacement that is delivered through the chest without open heart surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't detailed here, typical risks may include bleeding, infection, blood vessel complications, irregular heart rhythms, stroke, need for permanent pacemaker or reoperation.

TIARA-I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe symptoms from mitral valve leakage.

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

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I have severe heart failure.

TIARA-I Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom From All-cause Mortality and Major Adverse Events

Secondary outcome measures

Days Alive and Out of Hospital

Medical Devices

Individual 30 Day Rates of Device and Procedure Related Major Adverse Events

+3 more

TIARA-I Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitral valve replacement

2019

Completed Phase 4

~150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neovasc Inc.Lead Sponsor

7 Previous Clinical Trials

1,388 Total Patients Enrolled

Anson Cheung, MDStudy ChairUniversity of British Columbia

Media Library

Neovasc Tiara™ Mitral Valve System (Mitral Valve Replacement Device) Clinical Trial Eligibility Overview. Trial Name: NCT02276547 — N/A

Mitral Valve Regurgitation Research Study Groups: Treatment

Mitral Valve Regurgitation Clinical Trial 2023: Neovasc Tiara™ Mitral Valve System Highlights & Side Effects. Trial Name: NCT02276547 — N/A

Neovasc Tiara™ Mitral Valve System (Mitral Valve Replacement Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02276547 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are currently participating in this investigation?

"This medical trial is being conducted out of Northwestern University in Chicago, Washington University in St. Louis and Columbia Medical Center in New york City as well as other 9 sites around the USA."

Answered by AI

Are researchers still looking to add participants to this medical trial?

"Clinicaltrials.gov confirms that this trial, which was created on December 1st 2014 and last updated January 7th 2022, is not currently recruiting patients. However, there are 98 actively enrolling studies at the moment seeking volunteers."

Answered by AI

Recent research and studies

Circulation: Cardiovascular InterventionsJournal

Percutaneous Transcatheter Mitral Valve Replacement

De Backer, Ole, Nicolo Piazza, Shmuel Banai, Georg Lutter, Francesco Maisano, Howard C. Herrmann, Olaf W. Franzen, and Lars Søndergaard. 2014. “Percutaneous Transcatheter Mitral Valve Replacement”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.114.001607.

The Journal of Thoracic and Cardiovascular SurgeryJournal

2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease

Nishimura, Rick A., Catherine M. Otto, Robert O. Bonow, Blase A. Carabello, John P. Erwin III, Robert A. Guyton, Patrick T. O’Gara, et al.. 2014. “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2014.05.014.

The Journal of Thoracic and Cardiovascular SurgeryJournal

Updated Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation: The Valve Academic Research Consortium-2 Consensus Document

Kappetein, A. Pieter, Stuart J. Head, Philippe Généreux, Nicolo Piazza, Nicolas M. van Mieghem, Eugene H. Blackstone, Thomas G. Brott, et al.. 2013. “Updated Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation: The Valve Academic Research Consortium-2 Consensus Document”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/j.jtcvs.2012.09.002.

clinicaltrials.govStudy