Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Conditions
- Chronic Symptomatic Functional Tricuspid RegurgitationTricuspid Valve InsufficiencyHeart Valve Disease
- Interventions
- Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Registration Number
- NCT03225612
- Lead Sponsor
- Mitralign, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) 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.
- Primary Outcome Measures
Name Time Method Incidence of all-cause mortality at 30 days. 30-days Incidence of all-cause mortality at 30 days.
- Secondary Outcome Measures
Name Time Method Adverse Events Up to 60 months post procedure Rate of adverse events, including serious adverse events
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 procedureEchocardiographic 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
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
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)
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)
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)
Trial Locations
- Locations (11)
CardioVascular Center Frankfurt
🇩🇪Frankfurt, Germany
Herzzentrum Leipzig - Universitätsklinik
🇩🇪Leipzig, Germany
German Heart Center Munich
🇩🇪Munich, Germany
Ospedale San Raffaele
🇮🇹Milan, Italy
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
🇩🇪Hamburg, Germany
Herzzentrum Brandenburg in Bernau
🇩🇪Bernau bei Berlin, Germany
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E.
🇵🇹Porto, Portugal
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany