Chronic Symptomatic Functional Tricuspid Regurgitation, Heart Valve Disease, Tricuspid Valve Insufficiency
Conditions
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.
Interventions
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.
Sponsors
Genae
Regulatory and Clinical Research Institute Inc
CardioVascular Research Foundation, Korea
Mitralign, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all-cause mortality at 30 days. | 30-days | Incidence of all-cause mortality at 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Adverse Events | Up to 60 months post procedure | Rate of adverse events, including serious adverse events |
Countries
Germany, Italy, Netherlands, Portugal
Contacts
Primary ContactPatricia Keating
Backup ContactGisella Blanchette
Outcome results
None listed