Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:December 2014
End Date:February 2025
Contact:Josh D Carlson
Email:Jcarlson@neovasc.com
Phone:855-802-5180

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Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

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.

This is an international, multicenter, single arm, prospective, Early Feasibility Clinical
Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in
subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who
are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum
of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive
the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a
transcatheter mitral valve replacement (TMVR) procedure.

Inclusion Criteria:

- Severe symptomatic mitral regurgitation (Stage D)

- High surgical risk for open mitral valve surgery

- Subject meets the anatomical eligibility criteria for available size(s)

- NYHA Class III or IV heart failure

Exclusion Criteria:

- DMR deemed by the heart team to be operable.

- Prohibitive risk, deemed too frail or listed for cardiac transplant.

- Unsuitable cardiac structure
We found this trial at
7
sites
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Mark Reisman, MD
Phone: 206-616-6768
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Raj Makkar, MD
Phone: 310-423-6152
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Antwerpen,
Principal Investigator: Stefan Verheye, MD, PhD
Phone: 32 49 6862375
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Antwerpen,
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Patrick M McCarthy, MD
Phone: 312-926-4000
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Chicago, IL
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Detroit, Michigan 48202
Principal Investigator: Adam Greenbaum, MD
Phone: 313-916-7430
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Detroit, MI
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Saint Louis, Missouri 63110
Principal Investigator: John Lasala, MD
Phone: 855-825-8457
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Saint Louis, MO
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