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Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System (TIARA-I)

This study is currently recruiting participants.
Verified October 2017 by Neovasc Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02276547
First Posted: October 28, 2014
Last Update Posted: October 31, 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
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Condition Intervention
Mitral Valve Regurgitation Device: Mitral valve replacement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

Further study details as provided by Neovasc Inc.:

Primary Outcome Measures:
  • Freedom from all-cause mortality and major adverse events defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention [ Time Frame: 30 days from the implant procedure or hospital discharge (whichever is later) ]

Secondary Outcome Measures:
  • Number and percentage of subjects with all-cause mortality, disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding and cardiac surgical or transcatheter reintervention [ Time Frame: 30 days, 90 days, 180 days and annually to five years ]
  • Individual 30 day rates of device and procedure related major adverse events [ Time Frame: 30 days ]
  • Number and percentage of subjects with progression of heart failure [ Time Frame: One year ]
  • Device success; delivery and deployment of the device in the correct position and retrieval of delivery catheter [ Time Frame: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years ]
  • Performance measured by NYHA Functional Class, 6 Minute Walk Test and the Kansas City Cardiomyopathy Questionnaire comparing baseline to each time period [ Time Frame: 30 days, 90 days, 180 days and annually for five years ]
  • Days alive and out of hospital [ Time Frame: At one year ]

Estimated Enrollment: 30
Study Start Date: December 2014
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2018 (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: Mitral valve replacement
Transcatheter mitral valve replacement
Other Name: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System

Detailed Description:

This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.

  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 symptomatic mitral regurgitation (Stage D)
  • High surgical risk for open mitral valve surgery
  • Subject meets the anatomical eligibility criteria for available size(s)
  • NYHA Class III or IV heart failure

Exclusion Criteria:

  • DMR deemed by the heart team to be operable.
  • Prohibitive risk, deemed too frail or listed for cardiac transplant.
  • Unsuitable cardiac structure
  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): NCT02276547


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
United States, California
Cedars Sinai Medical Center Terminated
Los Angeles, California, United States, 90048
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact    312-926-4000    heartresearch@northwestern.edu   
Principal Investigator: Patrick M McCarthy, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48188
Contact: Ashley Hill    313-916-7430    ahill13@hfhs.org   
Principal Investigator: Adam Greenbaum, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: John Lasala, MD    855-825-8457      
Principal Investigator: John Lasala, MD         
United States, New York
Columbia University Medical Center Terminated
New York, New York, United States, 10032
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Kate Jordan    206-616-6768    jordank1@cardiology.washington.edu   
Principal Investigator: Mark Reisman, MD         
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, B 2060
Contact: Stefan Verheye, MD, PhD    32 49 6862375    stefan.verheye@gmail.com   
Principal Investigator: Stefan Verheye, MD, PhD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Nasim Boroumand    780-407-2667      
Principal Investigator: Steven Meyer, MD         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Miroslav Svetik, MD, IMG    604-806-9981    msvetik@providencehealth.bc.ca   
Principal Investigator: Anson Cheung, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Stephanie Fox, BA, RRT    519-685-8500 ext 35031    stephanie.fox@lhsc.on.ca   
Principal Investigator: Bob Kiaii, MD         
Sponsors and Collaborators
Neovasc Inc.
Investigators
Study Chair: Anson Cheung, MD University of British Columbia
  More Information

Additional Information:
Publications:
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. Review. Erratum in: J Thorac Cardiovasc Surg. 2014 Oct 21;64(16):1763. Dosage error in article text.

Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT02276547     History of Changes
Other Study ID Numbers: 047-CPT-001
First Submitted: October 21, 2014
First Posted: October 28, 2014
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neovasc Inc.:
Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery

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