SCOUT: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Label Non-randomized, open label clinical study that intends to treat up to 30 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. |
Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
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≥18 and ≤85 years old;
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NYHA II - IV;
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Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
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LVEF ≥35%
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Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29 mm/m2 (Superscript))
Exclusion Criteria:
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Pregnant or lactating female;
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Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
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Previous tricuspid valve repair or replacement;
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Severe coronary artery disease;
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MI or known unstable angina within the 30-days prior to the index procedure;
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Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
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Chronic oral steroid use (≥6 months);
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Life expectancy of less than 12-months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 2 | Kaiser Permanente | San Francisco | California | United States | 94115 |
| 3 | MedStar Washington Hospital Center | Washington, D.C. | District of Columbia | United States | 20010 |
| 4 | Delray Medical Center | Delray Beach | Florida | United States | 33484 |
| 5 | Piedmont Healthcare | Atlanta | Georgia | United States | 30309 |
| 6 | Northwestern University / Bluhm Cardiovascular Institute | Chicago | Illinois | United States | 60611 |
| 7 | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | United States | 55407 |
| 8 | Columbia University Medical Center / New York-Presbyterian Hospital | New York | New York | United States | 10032 |
| 9 | Houston Methodist | Houston | Texas | United States | 77030 |
| 10 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 11 | Swedish Medical Center | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- Mitralign, Inc.
Investigators
- Principal Investigator: Rebecca Hahn, MD, Columbia Unviersity Medical Center / New York-Presbyterian Hospital
- Principal Investigator: Christopher Meduri, MD, MPH, Piedmont Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLPR-010