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

Mitralign

Status: Unknown

Conditions: Tricuspid Valve Insufficiency; Chronic Symptomatic Functional Tricuspid Regurgitation; Heart Valve Disease

Treatments: Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02574650

CLPR-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Open Label

Experimental group

Description:

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.

Treatment:

Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)