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

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.

• Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) (Device): 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.

Primary outcomes

• Incidence of all-cause mortality at 30 days. [30-days]: Incidence of all-cause mortality at 30 days.

Secondary outcomes

• Technical success [30 Days]: 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
• Echocardiographic variable: tenting height (maximum, any view) [Change from Baseline at 30 days]: 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
• Echocardiographic variable: tenting area (maximum, any view) [Change from Baseline at 30 days]: 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
• Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view) [Change from Baseline at 30 days]: 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
• Tricuspid regurgitation as determined by echocardiographic methods [Change from Baseline at 30 days]: As measured by the PISA method and the Quantitative Flow method
• Percent tricuspid regurgitation from baseline to 30-days [Change from Baseline at 30 days]: Percent tricuspid regurgitation from baseline to 30-days
• Adverse Events [Up to 60 months post procedure]: Rate of adverse events, including serious adverse events
• 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]: Change in New York Heart Association (NYHA) classification
• Six-Minute Walk Test (6MWT) [Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure]: Change in the Six-Minute Walk Test (6MWT)
• 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]: Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)
• 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]: Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)

Sex: All, ages: 18 Years to 85 Years

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

• Prof. Dr. med Joachim Schofer, Principal investigator, Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH