Tiara™ Transcatheter Mitral Valve Replacement Study

Not Applicable

Active, not recruiting

• Conditions: Mitral Valve Regurgitation

• Registration Number: NCT03039855
• Lead Sponsor: Shockwave Medical, Inc.

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2020-06-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of Mitral Regurgitation to optimal or acceptable	30 days
Freedom from all-cause mortality	30 days
Freedom from major adverse events	30 Days

Secondary Outcome Measures

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

Trial Locations

Locations (20)

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

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