Chronic Symptomatic Functional Tricuspid Regurgitation, Heart Valve Disease, Tricuspid Valve Insufficiency
Conditions
Brief summary
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR). 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 and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-years post implantation.
Interventions
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Sponsors
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 - IV; * Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use; * LVEF ≥35% * Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29 mm/m2 (Superscript))
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 |
|---|---|---|
| Technical success at 30-days | 30-days | Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary safety and performance endpoints mid-term and long-term | 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months | The secondary objectives of the study are to evaluate the acute, mid-term and long-term safety of the device and effects of the device on performance, functional and quality of life parameters, as well as technical, procedural and individual patient successes. |
| Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked | 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months | Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated. |
Countries
United States
Contacts
Primary ContactGisella Blanchette
Backup ContactSara Vidmar
Outcome results
None listed