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

Status unconfirmed · Not applicable

Conditions studied: Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease

In brief

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.

Key facts

Study ID

NCT02574650

Run by

Mitralign, Inc.

People needed

30

Starts

2015-11-01

Expected to finish

2019-05-01

Last updated by the study team

2017-10-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Kaiser Permanente — San Francisco, California, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Delray Medical Center — Delray Beach, Florida, United States (enrolling)
• Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
• Northwestern University / Bluhm Cardiovascular Institute — Chicago, Illinois, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Columbia University Medical Center / New York-Presbyterian Hospital — New York, New York, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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