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

Primary Purpose

Mitral Valve Regurgitation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TIARA valve and transapical delivery system
Sponsored by
Neovasc Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kerckhoff Klinik Herzzentrum-Herzchirurgie
  • Herz- und Diabeteszentrum NRW
  • Schüchtermann-Klinik
  • Deutches Herzzentrum Berlin
  • Immanuel Klinikum Bernau und Herzzentrum Brandenburg
  • St.-Johannes-Hospital, Klinik für Innere Medizin I
  • Universitätsklinikum Halle
  • Universitasklinikum Hamburg-Eppendorf
  • Herzzentrum Leipzig
  • Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
  • Sana Herzchirurgie Stuttgart GmbH
  • Tel Aviv Medical Center
  • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
  • Fondazione Toscana 'Gabriele Monasterio'
  • Ospedale San Raffaele
  • IRCCS Policlinico San Donato
  • St. Antonius Hospital
  • Hospital Clinico San Carlos
  • Edinburgh Heart Centre Royal Infirmary
  • King's College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Freedom from all-cause mortality
Freedom from major adverse events
Reduction of Mitral Regurgitation to optimal or acceptable

Secondary Outcome Measures

Freedom from all-cause mortality
Freedom from major adverse events
Technical success
Per MVARC criteria
Procedural success
Per MVARC criteria
Device success
Per MVARC criteria
NYHA Functional Class
Number of subjects with improved NYHA class
6 Minute Walk Test
Increase in distance (m) from baseline
Kansas City Cardiomyopathy Questionnaire
Improvement in quality of life
Hemodynamic performance
Assessed by echocardiography
Patient success
Per MVARC Criteria

Full Information

First Posted
January 16, 2017
Last Updated
August 4, 2020
Sponsor
Neovasc Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03039855
Brief Title
Tiara™ Transcatheter Mitral Valve Replacement Study
Acronym
TIARA-II
Official Title
Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neovasc Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Detailed Description
The TIARA-II study is an international, multicenter, single-arm, prospective, safety and performance clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
Mitral, Regurgitation, Heart valve, Transcatheter, Transapical, Functional, Degenerative, TMVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Intervention Type
Device
Intervention Name(s)
TIARA valve and transapical delivery system
Other Intervention Name(s)
TIARA Mitral Transcatheter Heart Valve, TIARA Transapical Delivery System
Intervention Description
Transcatheter mitral valve replacement
Primary Outcome Measure Information:
Title
Freedom from all-cause mortality
Time Frame
30 days
Title
Freedom from major adverse events
Time Frame
30 Days
Title
Reduction of Mitral Regurgitation to optimal or acceptable
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Freedom from all-cause mortality
Time Frame
90 days, 180 days, one year and annually to five years
Title
Freedom from major adverse events
Time Frame
90 days, 180 days, one year and annually to five years
Title
Technical success
Description
Per MVARC criteria
Time Frame
Day 0
Title
Procedural success
Description
Per MVARC criteria
Time Frame
30 days
Title
Device success
Description
Per MVARC criteria
Time Frame
Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
Title
NYHA Functional Class
Description
Number of subjects with improved NYHA class
Time Frame
30 days, 90 days, 180 days and once annually for five years
Title
6 Minute Walk Test
Description
Increase in distance (m) from baseline
Time Frame
30 days, 90 days, 180 days and once annually for five years
Title
Kansas City Cardiomyopathy Questionnaire
Description
Improvement in quality of life
Time Frame
30 days, 90 days, 180 days and once annually for five years
Title
Hemodynamic performance
Description
Assessed by echocardiography
Time Frame
30 days, 90 days, 180 days and once annually for five years
Title
Patient success
Description
Per MVARC Criteria
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kerckhoff Klinik Herzzentrum-Herzchirurgie
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Schüchtermann-Klinik
City
Bad Rothenfelde
ZIP/Postal Code
49214
Country
Germany
Facility Name
Deutches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Immanuel Klinikum Bernau und Herzzentrum Brandenburg
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
St.-Johannes-Hospital, Klinik für Innere Medizin I
City
Dortmund
ZIP/Postal Code
44229
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitasklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
City
Rotenburg An Der Fulda
Country
Germany
Facility Name
Sana Herzchirurgie Stuttgart GmbH
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione Toscana 'Gabriele Monasterio'
City
Massa
ZIP/Postal Code
54100
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Edinburgh Heart Centre Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE59RS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.neovasc.com
Description
Company website with product information

Learn more about this trial

Tiara™ Transcatheter Mitral Valve Replacement Study

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