Clinical trial NCT02574650: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
Official title: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Symptomatic Functional Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Heart Valve Disease
Lead sponsor: Mitralign, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical success at 30-days
timeFrame: 30-days
Secondary outcomes:
measure: Secondary safety and performance endpoints mid-term and long-term
timeFrame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
measure: 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
timeFrame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Washington, D.C.
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Chicago
country: United States
facility: Northwestern University / Bluhm Cardiovascular Institute
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center / New York-Presbyterian Hospital
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Columbia Unviersity Medical Center / New York-Presbyterian Hospital
name: Rebecca Hahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Healthcare
name: Christopher Meduri, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahn RT, Meduri CU, Davidson CJ, Lim S, Nazif TM, Ricciardi MJ, Rajagopal V, Ailawadi G, Vannan MA, Thomas JD, Fowler D, Rich S, Martin R, Ong G, Groothuis A, Kodali S. Early Feasibility Study of a Transcatheter Tricuspid Valve Annuloplasty: SCOUT Trial 30-Day Results. J Am Coll Cardiol. 2017 Apr 11;69(14):1795-1806. doi: 10.1016/j.jacc.2017.01.054.