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

ShockWave Medical

Status: Active, not recruiting

Conditions: Mitral Valve Regurgitation

Treatments: Device: TIARA valve and transapical delivery system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03039855

047-CPT-003

Details and patient eligibility

About

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

Full description

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

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Device: TIARA valve and transapical delivery system