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

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ClinicalTrials.gov Identifier: NCT03225612
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Genae
Regulatory and Clinical Research Institute Inc
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Mitralign, Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE May 22, 2017
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
Incidence of all-cause mortality at 30 days. [ Time Frame: 30-days ]
Incidence of all-cause mortality at 30 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03225612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Official Title  ICMJE Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Symptomatic Functional Tricuspid Regurgitation
  • Tricuspid Valve Insufficiency
  • Heart Valve Disease
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia Keating 978-863-2445 pkeating@mitralign.com
Contact: Gisella Blanchette 978.863.2435 gblanchette@mitralign.com
Listed Location Countries  ICMJE Germany,   Italy,   Netherlands,   Portugal
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT03225612
Other Study ID Numbers  ICMJE CLPR-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mitralign, Inc.
Study Sponsor  ICMJE Mitralign, Inc.
Collaborators  ICMJE
  • Genae
  • Regulatory and Clinical Research Institute Inc
  • CardioVascular Research Foundation, Korea
Investigators  ICMJE
Principal Investigator: Prof. Dr. med Joachim Schofer Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH
PRS Account Mitralign, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP