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Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)

This study is currently recruiting participants.
Verified October 2017 by Neovasc Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03039855
First Posted: February 1, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Neovasc Inc.
  Purpose
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Condition Intervention
Mitral Valve Regurgitation Device: TIARA valve and transapical delivery system

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)

Further study details as provided by Neovasc Inc.:

Primary Outcome Measures:
  • Freedom from all-cause mortality [ Time Frame: 30 days ]
  • Freedom from major adverse events [ Time Frame: 30 Days ]
  • Reduction of Mitral Regurgitation to optimal or acceptable [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Freedom from all-cause mortality [ Time Frame: 90 days, 180 days, one year and annually to five years ]
  • Freedom from major adverse events [ Time Frame: 90 days, 180 days, one year and annually to five years ]
  • Technical success [ Time Frame: Day 0 ]
    Per MVARC criteria

  • Procedural success [ Time Frame: 30 days ]
    Per MVARC criteria

  • Device success [ Time Frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years ]
    Per MVARC criteria

  • NYHA Functional Class [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Number of subjects with improved NYHA class

  • 6 Minute Walk Test [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Increase in distance (m) from baseline

  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Improvement in quality of life

  • Hemodynamic performance [ Time Frame: 30 days, 90 days, 180 days and once annually for five years ]
    Assessed by echocardiography

  • Patient success [ Time Frame: 1 year ]
    Per MVARC Criteria


Estimated Enrollment: 115
Study Start Date: January 2017
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Device: TIARA valve and transapical delivery system
Transcatheter mitral valve replacement
Other Name: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

Detailed Description:
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe mitral regurgitation
  • High surgical risk for open mitral valve surgery
  • Subject meets anatomical eligibility criteria

Exclusion Criteria:

  • Deemed too frail by objective frailty assessments
  • Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant
  • Unsuitable cardiac structure
  • Clinically significant untreated Coronary Artery Disease (CAD)
  • Subjects on chronic dialysis
  • Pregnant or planning pregnancy within next 12 months
  • Documented bleeding or coagulation disorders
  • Active infections requiring antibiotic therapy
  • Subjects with a life expectancy less than 12 months
  Contacts and Locations
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): NCT03039855


Contacts
Contact: Josh D Carlson 855-802-5180 ext 310 Jcarlson@neovasc.com
Contact: Naomi J Tatarek, BSN 855-802-5180 ext 301 Ntatarek@neovasc.com

Locations
Germany
Kerckhoff Klinik Herzzentrum-Herzchirurgie Recruiting
Bad Nauheim, Germany, 61231
Contact: Prof. Dr. med. Thomas Walther    49 (0) 6032 996 2501    t.walther@kerckhoff-klinik.de   
Deutches Herzzentrum Berlin Recruiting
Berlin, Germany, 13353
Contact: Dr. med. Jörg Kempfert    +49 30 4593 2001    Kempfert@dhzb.de   
Universitätsklinikum Halle Recruiting
Halle, Germany, 06120
Contact: Prof. Dr. med. Hendrik Treede    +49 0345 557 2719    hendrik.treede@uk-halle.de   
Universitasklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Prof. Dr. med. Ulrich Schäfer    49 (0) 40 7410 53979    u.schaefer@uke.de   
Contact: Dr. med. Lenard Conradi    49 (0) 40 7410 58949    lconradi@uke.de   
Herzzentrum Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Dr. David Holzhey    +49 341 865-251039    david.Holzhey@helios-kliniken.de   
Italy
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore. Recruiting
Roma, RM, Italy, 00168
Contact: Piergiorgio Bruno, MD    +393479500341    piergiorgiob@yahoo.it   
Principal Investigator: Piergiorgio Bruno, MD         
Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Contact: Paolo Denti       denti.paolo@hsr.it   
Principal Investigator: Paolo Denti         
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Italy, 20097
Contact: Dr. Francesco Bedogni    39 02 527741    francescobedogni@tin.it   
Principal Investigator: Dr. Francesco Bedogni         
United Kingdom
Edinburgh Heart Centre Royal Infirmary Recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Prof. Neal Uren    +44 131 242 1046    neal.uren@nhs.net   
Contact: Dr. Miles Behan    +44 131 242 1048    miles.behan@nhslothian.scot.nhs.uk   
King's College Hospital Recruiting
London, United Kingdom, SE59RS
Contact: Prof. Olaf Wendler, MD PhD FRCS    +44 (0) 20 3299 4341    olaf.wendler@nhs.net   
Contact: Prof. Philip MacCarthy, BSc MBChB PhD FRCP    +44 (0) 20 3299 3750    mariemccarthy1@nhs.net   
Sponsors and Collaborators
Neovasc Inc.
  More Information

Additional Information:
Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT03039855     History of Changes
Other Study ID Numbers: 047-CPT-003
First Submitted: January 16, 2017
First Posted: February 1, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Neovasc Inc.:
Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
TMVR

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