SAFETY AND PERFORMANCE OF THE TRIALIGN PERCUTANEOUS TRICUSPID VALVE ANNULOPLASTY SYSTEM (PTVAS) FOR SYMPTOMATIC CHRONIC FUNCTIONAL TRICUSPID REGURGITATION

SAFETY AND PERFORMANCE OF THE TRIALIGN PERCUTANEOUS TRICUSPID VALVE ANNULOPLASTY SYSTEM (PTVAS) FOR SYMPTOMATIC CHRONIC FUNCTIONAL TRICUSPID REGURGITATION - SCOUT-II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45353

Enrollment

Registered

2017-08-03

Start date

2017-04-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic chronic functional tricuspid - leakage of the right heartvalve

Interventions

Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Trialign PTVAS System is designed to perform a percutaneous suture annuloplasty of the tricuspid annulus to treat chronic functiona

Percutaneous Valve Annuloplasty System

Pledgeted sutures

Tricuspid Regurgitation

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. >=18 and

Exclusion criteria

Exclusion criteria: 1. History of heart transplant 2. Severe uncontrolled hypertension (SBP >= 180 mmHg and/or DBP >= 110 mmHg) 3. Previous tricuspid valve repair or replacement (including artificial valve) 4. Presence of LVAD, trans-tricuspid pacemaker or defibrillator leads 5. Active endocarditis 6. Severe coronary artery disease

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: Incidence of all-cause mortality at 30 days.	—

Secondary

Measure	Time frame
Technical success, defined as freedom from death at 30 days with; 1) successful access, delivery and retrieval of the device delivery system; 2) deployment and correct positioning of the intended device(s) which is maintained and; 3) no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure 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: 1) Native Tricuspid valve morphology: - Tenting Height (maximum, any view) - Tenting Area (maximum, any view) *- Quantification of tricuspid valve and annular area 2) Tricuspid regurgitation as determined by echocardiographic methods at baseline and 30 days. - PISA (Proximal Isovelocity Surface Area) method - Quantitative flow method 3) Percent tricuspid regurgitation from baseline to 30-days Rate of adverse events, including serious adverse events Clinical Status Endpoints: 1) New York Heart Association (NYHA) classification 2) Six-minute walk test (6MWT) 3) Minnesota Living with Heart Failure Questionnaire (MLWHF) 4) EuroQol five dimensions questionnaire (EQ-5D) Change from baseline in clinical status endpoints and echocardiographic variables assessed by the Echocardiographic Core Lab will be measured at discharge, 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure.	—

Measure

Time frame

Technical success, defined as freedom from death at 30 days with; 1) successful access, delivery and retrieval of the device delivery system; 2) deployment and correct positioning of the intended device(s) which is maintained and; 3) no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure 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: 1) Native Tricuspid valve morphology: *- Tenting Height (maximum, any view) *- Tenting Area (maximum, any view) *- Quantification of tricuspid valve and annular area 2) Tricuspid regurgitation as determined by echocardiographic methods at baseline and 30 days. - PISA (Proximal Isovelocity Surface Area) method - Quantitative flow method 3) Percent tricuspid regurgitation from baseline to 30-days Rate of adverse events, including serious adverse events Clinical Status Endpoints: 1) New York Heart Association (NYHA) classification 2) Six-minute walk test (6MWT) 3) Minnesota Living with Heart Failure Questionnaire (MLWHF) 4) EuroQol five dimensions questionnaire (EQ-5D) Change from baseline in clinical status endpoints and echocardiographic variables assessed by the Echocardiographic Core Lab will be measured at discharge, 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)