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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03225612
• Date of registration: 14/06/2017
• Prospective Registration: No
• Primary sponsor: Mitralign, Inc.
• Public title: Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) SCOUT-II
• Scientific title: Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
• Date of first enrolment: May 22, 2017
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03225612
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France, Germany, Italy, Netherlands, Portugal

Contacts

• Name: Patricia Keating

• Name: Prof. Dr. med Joachim Schofer
• Affiliation: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tricuspid Valve Insufficiency

Heart Valve Disease

Chronic Symptomatic Functional Tricuspid Regurgitation

Intervention(s)

Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Primary Outcome(s)

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

Secondary Outcome(s)

Echocardiographic variable: tenting height (maximum, any view) [Time Frame: Change from Baseline at 30 days]

Six-Minute Walk Test (6MWT) [Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure]

Percent tricuspid regurgitation from baseline to 30-days [Time Frame: Change from Baseline at 30 days]

EuroQol Five Dimensions Questionnaire (EQ-5D) [Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure]

Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view) [Time Frame: Change from Baseline at 30 days]

Technical success [Time Frame: 30 Days]

Adverse Events [Time Frame: Up to 60 months post procedure]

Echocardiographic variable: tenting area (maximum, any view) [Time Frame: Change from Baseline at 30 days]

Minnesota Living with Heart Failure Questionnaire (MLWHF) [Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure]

New York Heart Association (NYHA) classification [Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure]

Tricuspid regurgitation as determined by echocardiographic methods [Time Frame: Change from Baseline at 30 days]

Secondary ID(s)

CLPR-011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CardioVascular Research Foundation, Korea

Regulatory and Clinical Research Institute Inc

Genae