Tiara™ Transcatheter Mitral Valve Replacement Study

Mitral Valve Regurgitation Clinical Trial

— TIARA-II  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03039855
• Other study ID #: 047-CPT-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Neovasc Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: January 2026
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• TIARA valve and transapical delivery system
Transcatheter mitral valve replacement

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik Herzzentrum-Herzchirurgie	Bad Nauheim
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Schüchtermann-Klinik	Bad Rothenfelde
Germany	Deutches Herzzentrum Berlin	Berlin
Germany	Immanuel Klinikum Bernau und Herzzentrum Brandenburg	Bernau
Germany	St.-Johannes-Hospital, Klinik für Innere Medizin I	Dortmund
Germany	Universitätsklinikum Halle	Halle
Germany	Universitasklinikum Hamburg-Eppendorf	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg	Rotenburg An Der Fulda
Germany	Sana Herzchirurgie Stuttgart GmbH	Stuttgart
Israel	Tel Aviv Medical Center	Tel Aviv
Italy	Fondazione Toscana 'Gabriele Monasterio'	Massa
Italy	Ospedale San Raffaele	Milan
Italy	Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.	Roma	RM
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Netherlands	St. Antonius Hospital	Nieuwegein
Spain	Hospital Clinico San Carlos	Madrid
United Kingdom	Edinburgh Heart Centre Royal Infirmary	Edinburgh
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Neovasc Inc.

Countries where clinical trial is conducted

Germany,  Israel,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from all-cause mortality		30 days
Primary	Freedom from major adverse events		30 Days
Primary	Reduction of Mitral Regurgitation to optimal or acceptable		30 days
Secondary	Freedom from all-cause mortality		90 days, 180 days, one year and annually to five years
Secondary	Freedom from major adverse events		90 days, 180 days, one year and annually to five years
Secondary	Technical success	Per MVARC criteria	Day 0
Secondary	Procedural success	Per MVARC criteria	30 days
Secondary	Device success	Per MVARC criteria	Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
Secondary	NYHA Functional Class	Number of subjects with improved NYHA class	30 days, 90 days, 180 days and once annually for five years
Secondary	6 Minute Walk Test	Increase in distance (m) from baseline	30 days, 90 days, 180 days and once annually for five years
Secondary	Kansas City Cardiomyopathy Questionnaire	Improvement in quality of life	30 days, 90 days, 180 days and once annually for five years
Secondary	Hemodynamic performance	Assessed by echocardiography	30 days, 90 days, 180 days and once annually for five years
Secondary	Patient success	Per MVARC Criteria	1 year

External Links

•   Company website with product information