Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. 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
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A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Official Title
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Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

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

Intervention / Treatment
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* Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation; ≥18 and ≤85 years old; NYHA II, III, or ambulatory IV; Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use; patient is at high risk for open heart valve surgery LVEF ≥35% Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Non-randomized, open label clinical study that intends to treat up to 60 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. | Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)<br>* Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all-cause mortality at 30 days. | Incidence of all-cause mortality at 30 days. | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success, defined as freedom from death at 30 days with: successful access, delivery and retrieval of the device delivery system; deployment and correct positioning of the intended device(s) which is maintained and; no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure | 30 Days | 
| Echocardiographic variable: tenting height (maximum, any view) | Echocardiographic variables assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device | Change from Baseline at 30 days | 
| Echocardiographic variable: tenting area (maximum, any view) | Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device | Change from Baseline at 30 days | 
| Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view) | Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device | Change from Baseline at 30 days | 
| Tricuspid regurgitation as determined by echocardiographic methods | As measured by the PISA method and the Quantitative Flow method | Change from Baseline at 30 days | 
| Percent tricuspid regurgitation from baseline to 30-days | Percent tricuspid regurgitation from baseline to 30-days | Change from Baseline at 30 days | 
| Adverse Events | Rate of adverse events, including serious adverse events | Up to 60 months post procedure | 
| New York Heart Association (NYHA) classification | Change in New York Heart Association (NYHA) classification | Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure | 
| Six-Minute Walk Test (6MWT) | Change in the Six-Minute Walk Test (6MWT) | Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure | 
| Minnesota Living with Heart Failure Questionnaire (MLWHF) | Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF) | Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure | 
| EuroQol Five Dimensions Questionnaire (EQ-5D) | Score on the EuroQol Five Dimensions Questionnaire (EQ-5D) | Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure |