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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Mitralign, Inc.
Sponsor:
Information provided by (Responsible Party):
Mitralign, Inc.
ClinicalTrials.gov Identifier:
NCT02574650
First received: October 9, 2015
Last updated: July 26, 2017
Last verified: July 2017
  Purpose

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 Intervention
Chronic Symptomatic Functional Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve Disease Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Study Type: Interventional
Study Design: 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

Further study details as provided by Mitralign, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 30
Study Start Date: November 2015
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02574650

Contacts
Contact: Gisella Blanchette 978-863-2435 gblanchette@mitralign.com
Contact: Sara Vidmar 651-338-2475 svidmar@mitralign.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Saibal Kar, MD    310-423-3977    saibal.kar2@cshs.org   
Principal Investigator: Saibal Kar, 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    satlerlowell@gmail.com   
Principal Investigator: Lowell Satler, MD         
United States, Florida
Delray Medical Center Recruiting
Delray Beach, Florida, United States, 33484
Contact: Laura Hudson    561-495-3145    Laura.Hudson@tenethealth.com   
Principal Investigator: Brijeshwar Maini, MD         
United States, Georgia
Piedmont Healthcare Recruiting
Atlanta, Georgia, United States, 30309
Contact: Christopher Meduri, MD    404-605-6517    christopher.meduri@piedmont.org   
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    srich@nm.org   
Principal Investigator: Stuart Rich, MD         
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    rth2@cumc.columbia.edu   
Principal Investigator: Rebecca Hahn, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Scott Lim, MD    434-982-1058    sl9pc@virginia.edu   
Principal Investigator: Scott Lim, MD         
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
  More Information

Responsible Party: Mitralign, Inc.
ClinicalTrials.gov Identifier: NCT02574650     History of Changes
Other Study ID Numbers: CLPR-010
Study First Received: October 9, 2015
Last Updated: July 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017