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

October 26, 2017 updated by: Mitralign, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente
        • Contact:
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Delray Medical Center
        • Principal Investigator:
          • Brijeshwar Maini, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University / Bluhm Cardiovascular Institute
        • Contact:
          • Stuart Rich, MD
          • Phone Number: 312-695-9979
          • Email: srich@nm.org
        • Principal Investigator:
          • Stuart Rich, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Principal Investigator:
          • Mario Goessl, MD, PhD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center / New York-Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Rebecca Hahn, MD
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
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.
24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitralign, Inc.

Investigators

  • Principal Investigator: Rebecca Hahn, MD, Columbia Unviersity Medical Center / New York-Presbyterian Hospital
  • Principal Investigator: Christopher Meduri, MD, MPH, Piedmont Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLPR-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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