Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Overview

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. 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.

Full Title of Study: “Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2018

Detailed Description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Interventions

  • Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
    • Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.

Arms, Groups and Cohorts

  • Experimental: Open Label
    • Non-randomized, open label clinical study that intends to treat up to 60 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of all-cause mortality at 30 days.
    • Time Frame: 30-days
    • Incidence of all-cause mortality at 30 days.

Secondary Measures

  • Technical success
    • Time Frame: 30 Days
    • Technical success, defined as freedom from death at 30 days with: successful access, delivery and retrieval of the device delivery system; deployment and correct positioning of the intended device(s) which is maintained and; no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
  • Echocardiographic variable: tenting height (maximum, any view)
    • Time Frame: Change from Baseline at 30 days
    • Echocardiographic variables assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device
  • Echocardiographic variable: tenting area (maximum, any view)
    • Time Frame: Change from Baseline at 30 days
    • Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device
  • Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)
    • Time Frame: Change from Baseline at 30 days
    • Echocardiographic variable assessed by the Echocardiographic Core Lab at baseline and 30-days reflecting the severity of tricuspid pathology and the response to the Trialign device
  • Tricuspid regurgitation as determined by echocardiographic methods
    • Time Frame: Change from Baseline at 30 days
    • As measured by the PISA method and the Quantitative Flow method
  • Percent tricuspid regurgitation from baseline to 30-days
    • Time Frame: Change from Baseline at 30 days
    • Percent tricuspid regurgitation from baseline to 30-days
  • Adverse Events
    • Time Frame: Up to 60 months post procedure
    • Rate of adverse events, including serious adverse events
  • New York Heart Association (NYHA) classification
    • Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
    • Change in New York Heart Association (NYHA) classification
  • Six-Minute Walk Test (6MWT)
    • Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
    • Change in the Six-Minute Walk Test (6MWT)
  • Minnesota Living with Heart Failure Questionnaire (MLWHF)
    • Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
    • Score on the Minnesota Living with Heart Failure Questionnaire (MLWHF)
  • EuroQol Five Dimensions Questionnaire (EQ-5D)
    • Time Frame: Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure
    • Score on the EuroQol Five Dimensions Questionnaire (EQ-5D)

Participating in This Clinical Trial

Inclusion Criteria

  • Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation; – ≥18 and ≤85 years old; – NYHA II, III, or ambulatory IV; – Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use; – patient is at high risk for open heart valve surgery – LVEF ≥35% – Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2) 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitralign, Inc.
  • Collaborator
    • Genae
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prof. Dr. med Joachim Schofer, Principal Investigator, Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
  • Overall Contact(s)
    • Patricia Keating, 978-863-2445, pkeating@mitralign.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.