Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.

Heart Valve Disease Clinical Trial

— SCOUT  

Official title:

Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574650
• Other study ID #: CLPR-010
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2015
• Last updated: October 26, 2017
• Start date: November 2015
• Est. completion date: May 2019

Study information

• Verified date: October 2017
• Source: Mitralign, Inc.
• Contact: Gisella Blanchette
• Phone: 978-863-2435
• Email: gblanchette[@]mitralign.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Symptomatic Functional Tricuspid Regurgitation
• Heart Valve Disease
• Heart Valve Diseases
• Tricuspid Valve Insufficiency

Intervention

Device:
• Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.

Locations

Country	Name	City	State
United States	Piedmont Healthcare	Atlanta	Georgia
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University / Bluhm Cardiovascular Institute	Chicago	Illinois
United States	Delray Medical Center	Delray Beach	Florida
United States	Houston Methodist	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Columbia University Medical Center / New York-Presbyterian Hospital	New York	New York
United States	Kaiser Permanente	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	MedStar Washington Hospital Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Mitralign, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success at 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.	30-days
Secondary	Secondary safety and performance endpoints mid-term and long-term	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.	24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Secondary	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	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.	24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months