Tiara™ Transcatheter Mitral Valve Replacement Study

Shockwave Medical, Inc.157 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Mitral Valve Regurgitation

Interventions

TIARA valve and transapical delivery systemDEVICE

Transcatheter mitral valve replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Kerckhoff Klinik Herzzentrum-Herzchirurgie

Bad Nauheim, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Outcomes

Primary Outcomes

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 Outcomes

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

Per MVARC criteria

Time frame: Day 0

Procedural success

Per MVARC criteria

Time frame: 30 days

Device success

Per MVARC criteria

Time frame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years

NYHA Functional Class

Number of subjects with improved NYHA class

Time frame: 30 days, 90 days, 180 days and once annually for five years

6 Minute Walk Test

Increase in distance (m) from baseline

Time frame: 30 days, 90 days, 180 days and once annually for five years

Data from ClinicalTrials.gov

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