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

Not Applicable

• Conditions: Heart Valve Disease; Tricuspid Valve Insufficiency; Chronic Symptomatic Functional Tricuspid Regurgitation
• Interventions: Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

• Registration Number: NCT02574650
• Lead Sponsor: Mitralign, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-14
• Study Start: 2015-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27
• Primary Completion: 2018-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)	Non-randomized, open label clinical study that intends to treat up to 30 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.

Primary Outcome Measures

Name	Time	Method
Technical success at 30-days	30-days	Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.

Secondary Outcome Measures

Name	Time	Method
Secondary safety and performance endpoints mid-term and long-term	24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months	The secondary objectives of the study are to evaluate the acute, mid-term and long-term safety of the device and effects of the device on performance, functional and quality of life parameters, as well as technical, procedural and individual patient successes.
Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked	24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months	Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated.

Trial Locations

Locations (11)

Piedmont Healthcare; 🇺🇸 Atlanta, Georgia, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, D.C., District of Columbia, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States

Northwestern University / Bluhm Cardiovascular Institute; 🇺🇸 Chicago, Illinois, United States

Columbia University Medical Center / New York-Presbyterian Hospital; 🇺🇸 New York, New York, United States