Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:10/29/2017
Start Date:November 2015
End Date:May 2019
Contact:Gisella Blanchette
Email:gblanchette@mitralign.com
Phone:978-863-2435

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Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

The purpose of this study is to assess the early safety and performance of the Mitralign
Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic
chronic functional tricuspid regurgitation (FTR).

The procedure will be performed with the PTVAS device using a non-surgical percutaneous
approach to tricuspid valve repair in patients who have FTR with a minimum of moderate
tricuspid regurgitation.

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic
functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The
study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be
conducted through 2-years post implantation.

Inclusion Criteria:

- Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid
regurgitation;

- ≥18 and ≤85 years old;

- NYHA II - IV;

- Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on
diuretic use;

- LVEF ≥35%

- Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29
mm/m2 (Superscript))

Exclusion Criteria:

- Pregnant or lactating female;

- Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);

- Previous tricuspid valve repair or replacement;

- Severe coronary artery disease;

- MI or known unstable angina within the 30-days prior to the index procedure;

- Any PCI within 30 days prior to the index procedure or planned 3 months post the index
procedure;

- Chronic oral steroid use (≥6 months);

- Life expectancy of less than 12-months
We found this trial at
11
sites
New York, New York 10032
Principal Investigator: Rebecca Hahn, MD
Phone: 212-305-7060
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar, MD
Phone: 310-423-3977
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Atlanta, Georgia 30309
Principal Investigator: Christopher Meduri, MD
Phone: 404-605-6517
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Scott Lim, MD
Phone: 434-982-1058
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chicago, Illinois 60611
Principal Investigator: Stuart Rich, MD
Phone: 312-695-9979
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Delray Beach, Florida 33431
Principal Investigator: Brijeshwar Maini, MD
Phone: 561-495-3145
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Houston, Texas 77030
Principal Investigator: Colin Baker, MD
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Minneapolis, Minnesota 55407
Principal Investigator: Mario Goessl, MD, PhD
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San Francisco, California 94115
Principal Investigator: Andrew Rassi, MD
Phone: 415-833-3480
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Sameer Gafoor, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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110 Irving Street Northwest
Washington, D.C., District of Columbia 20010
Principal Investigator: Lowell Satler, MD
Phone: 202-877-5975
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