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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02574650
Recruitment Status : Unknown
Verified October 2017 by Mitralign, Inc..
Recruitment status was:  Recruiting
First Posted : October 14, 2015
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Mitralign, Inc.

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
Chronic Symptomatic Functional Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve Disease Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Study Start Date : November 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

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.

Primary Outcome Measures :
  1. Technical success at 30-days [ Time Frame: 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 :
  1. Secondary safety and performance endpoints mid-term and long-term [ Time Frame: 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.

  2. 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 [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02574650

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Contact: Gisella Blanchette 978-863-2435
Contact: Sara Vidmar 651-338-2475

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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Saibal Kar, MD    310-423-3977   
Principal Investigator: Saibal Kar, MD         
Kaiser Permanente Recruiting
San Francisco, California, United States, 94115
Contact: Cristina Casias, RN, CCRC    415-833-3480   
Principal Investigator: Andrew Rassi, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Lowell Satler, MD    202-877-5975   
Principal Investigator: Lowell Satler, MD         
United States, Florida
Delray Medical Center Recruiting
Delray Beach, Florida, United States, 33484
Contact: Laura Hudson    561-495-3145   
Principal Investigator: Brijeshwar Maini, MD         
United States, Georgia
Piedmont Healthcare Recruiting
Atlanta, Georgia, United States, 30309
Contact: Christopher Meduri, MD    404-605-6517   
Principal Investigator: Christopher Meduri, MD         
United States, Illinois
Northwestern University / Bluhm Cardiovascular Institute Recruiting
Chicago, Illinois, United States, 60611
Contact: Stuart Rich, MD    312-695-9979   
Principal Investigator: Stuart Rich, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Karen Meyer   
Principal Investigator: Mario Goessl, MD, PhD         
United States, New York
Columbia University Medical Center / New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Rebecca Hahn, MD    212-305-7060   
Principal Investigator: Rebecca Hahn, MD         
United States, Texas
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Green   
Principal Investigator: Colin Baker, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Scott Lim, MD    434-982-1058   
Principal Investigator: Scott Lim, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Andrea Drouhard   
Principal Investigator: Sameer Gafoor, MD         
Sponsors and Collaborators
Mitralign, Inc.
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Principal Investigator: Rebecca Hahn, MD Columbia Unviersity Medical Center / New York-Presbyterian Hospital
Principal Investigator: Christopher Meduri, MD, MPH Piedmont Healthcare
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mitralign, Inc. Identifier: NCT02574650    
Other Study ID Numbers: CLPR-010
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases