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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
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Mitralign, Inc.

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.


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. 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Incidence of all-cause mortality at 30 days. [ Time Frame: 30-days ]
    Incidence of all-cause mortality at 30 days.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Percent tricuspid regurgitation from baseline to 30-days [ Time Frame: Change from Baseline at 30 days ]
    Percent tricuspid regurgitation from baseline to 30-days

  7. Adverse Events [ Time Frame: Up to 60 months post procedure ]
    Rate of adverse events, including serious adverse events

  8. 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

  9. 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)

  10. 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)

  11. 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)



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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03225612


Contacts
Contact: Patricia Keating 978-863-2445 pkeating@mitralign.com
Contact: Gisella Blanchette 978.863.2435 gblanchette@mitralign.com

Locations
Germany
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Contact: Maria Schuppe    +49 030 130 22 5101    maria.schuppe@vivantes.de   
Sub-Investigator: Hueseyin Ince, MD         
Principal Investigator: Stephan Kische, MD         
Herzzentrum Brandenburg in Bernau Recruiting
Bernau bei Berlin, Germany, 16321
Contact: Daniela Bettin    +49 33 3869 4604    d.bettin@immanuel.de   
Principal Investigator: Christian Butter, MD         
Sub-Investigator: Michael Neuss, MD         
CardioVascular Center Frankfurt Recruiting
Frankfurt, Germany, 60389
Contact: Sabine de Bruijn    +49 69 9794 7653    s.debruijn@cvcfrankfurt.de   
Principal Investigator: Horst Sievert, MD         
Sub-Investigator: Markus Reinartz, MD         
Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH Recruiting
Hamburg, Germany, 22527
Contact: Stefanie Bohme    +49 40 889006 830    Boehme@herz-hh.de   
Principal Investigator: Joachim Schofer, MD         
Sub-Investigator: Claudia Tiburtius, MD         
Herzzentrum Leipzig - Universitätsklinik Recruiting
Leipzig, Germany, 04289
Contact: Anne Kathrin Funkat    +49 341 865 1587    Anne-kathrin.funkat@leipzig-heart.de   
Principal Investigator: Philipp Lurz, MD         
Sub-Investigator: Joerg Seeburger, MD         
German Heart Center Munich Recruiting
Munich, Germany, 80636
Contact: Annemarie Stroh, PhD    +49 (0) 89 1218-2965    stroh@dhm.mhn.de   
Principal Investigator: Sabine Bleiziffer, MD         
Sub-Investigator: Getrud Goppel, MD         
Italy
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Vega Rusconi    +39 022 643 7362    Rusconi.vega@hsr.it   
Principal Investigator: Azeem Latib, MD         
Sub-Investigator: Eustachio Agricola, MD         
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Chiara Primerano    +39 050099 5326    chiaraprim@gmail.com   
Principal Investigator: Sonia Petronio, MD         
Sub-Investigator: Paolo Spontoni, MD         
Netherlands
Amphia Ziekenhuis Not yet recruiting
Breda, Netherlands, 4818 CK
Contact: Manola Smits    +31765955100    MSmits1@amphia.nl   
Principal Investigator: Peter den Heijer, MD         
Sub-Investigator: BJL van den Branden, MD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Greetje de Jong    +31 50 361 3348    g.h.de.jong@umcg.nl   
Principal Investigator: AFM van den Heuvel, MD         
Principal Investigator: P van der Harst, MD         
Portugal
C. Hospitalar Vila Nova de Gaia/Espinho, E.P.E. Recruiting
Porto, Portugal
Contact: Sonia M Dias    +351 934361674    sdias@CHVNG.MIN-SAUDE.PT   
Principal Investigator: Vasco Da Gama, MD         
Sub-Investigator: Jose Braga, MD         
Sponsors and Collaborators
Mitralign, Inc.
Genae
Regulatory and Clinical Research Institute
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Prof. Dr. med Joachim Schofer Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

Responsible Party: Mitralign, Inc.
ClinicalTrials.gov Identifier: NCT03225612     History of Changes
Other Study ID Numbers: CLPR-011
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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