NCT02276547

Brief Summary

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
3 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2021

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

5.1 years

First QC Date

October 21, 2014

Results QC Date

April 30, 2021

Last Update Submit

May 12, 2025

Conditions

Mitral Valve Regurgitation

Keywords

MitralRegurgitationHeart valveTranscatheterTransapicalFunctionalDegenerativeSymptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    From the time of implant procedure to 30 days or hospital discharge (whichever is later)

Secondary Outcomes (6)

  • 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

    30 days, 90 days, 180 days and annually to five years

  • Individual 30 Day Rates of Device and Procedure Related Major Adverse Events

    30 days

  • Number and Percentage of Subjects With Progression of Heart Failure

    One year

  • Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter

    Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years

  • Performance

    30 days, 90 days, 180 days and annually for five years

  • +1 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system

Device: Mitral valve replacement

Interventions

Mitral valve replacementDEVICE

Transcatheter mitral valve replacement

Also known as: TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Henry Ford Health System

Detroit, Michigan, 48188, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

ZNA Middelheim

Antwerp, B 2060, Belgium

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (3)

  • De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.

    PMID: 24944303BACKGROUND

  • 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. No abstract available.

    PMID: 24939033BACKGROUND

  • Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.

    PMID: 23084102BACKGROUND

Related Links

MeSH Terms

Conditions

Mitral Valve InsufficiencyGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Lisa Read, Clinical Study Manager
Organization
Neovasc
lread@neovasc.com
8558025180

Study Officials

  • Anson Cheung, MD

    University of British Columbia

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 28, 2014

Study Start

December 1, 2014

Primary Completion

January 6, 2020

Study Completion

August 1, 2025

Last Updated

May 20, 2025

Results First Posted

May 25, 2021

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)BE(1)US(6)