Tiara™ Transcatheter Mitral Valve Replacement Study
- Conditions
- Mitral Valve Regurgitation
- Interventions
- Device: TIARA valve and transapical delivery system
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 115
- Severe mitral regurgitation
- High surgical risk for open mitral valve surgery
- Subject meets anatomical eligibility 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
- Arm && Interventions
Group Intervention Description Treatment TIARA valve and transapical delivery system Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
- 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 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
Freedom from all-cause mortality 90 days, 180 days, one year and annually to five years 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
Schüchtermann-Klinik
🇩🇪Bad Rothenfelde, Germany
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
Deutches Herzzentrum Berlin
🇩🇪Berlin, Germany
Immanuel Klinikum Bernau und Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Universitätsklinikum Halle
🇩🇪Halle, Germany
Universitasklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
🇩🇪Rotenburg An Der Fulda, Germany
Sana Herzchirurgie Stuttgart GmbH
🇩🇪Stuttgart, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
🇮🇹Roma, RM, Italy
Tel Aviv Medical Center
🇮🇱Tel Aviv, Israel
Fondazione Toscana 'Gabriele Monasterio'
🇮🇹Massa, Italy
Ospedale San Raffaele
🇮🇹Milan, Italy
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Italy
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Edinburgh Heart Centre Royal Infirmary
🇬🇧Edinburgh, United Kingdom
St.-Johannes-Hospital, Klinik für Innere Medizin I
🇩🇪Dortmund, Germany
King's College Hospital
🇬🇧London, United Kingdom