Clinical trial NCT03039855: Tiara™ Transcatheter Mitral Valve Replacement Study
Official title: Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
TMVR
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from all-cause mortality
timeFrame: 30 days
measure: Freedom from major adverse events
timeFrame: 30 Days
measure: Reduction of Mitral Regurgitation to optimal or acceptable
timeFrame: 30 days
Secondary outcomes:
measure: Freedom from all-cause mortality
timeFrame: 90 days, 180 days, one year and annually to five years
measure: Freedom from major adverse events
timeFrame: 90 days, 180 days, one year and annually to five years
measure: Technical success
timeFrame: Day 0
measure: Procedural success
timeFrame: 30 days
measure: Device success
timeFrame: Day 0, Day 10, 30 days, 90 days, 180 days, one year and annually for five years
measure: NYHA Functional Class
timeFrame: 30 days, 90 days, 180 days and once annually for five years
measure: 6 Minute Walk Test
timeFrame: 30 days, 90 days, 180 days and once annually for five years
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 30 days, 90 days, 180 days and once annually for five years
measure: Hemodynamic performance
timeFrame: 30 days, 90 days, 180 days and once annually for five years
measure: Patient success
timeFrame: 1 year
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Herzzentrum-Herzchirurgie
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Berlin
country: Germany
facility: Deutches Herzzentrum Berlin
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau und Herzzentrum Brandenburg
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital, Klinik für Innere Medizin I
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Universitasklinikum Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Rotenburg An Der Fulda
country: Germany
facility: Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
city: Stuttgart
country: Germany
facility: Sana Herzchirurgie Stuttgart GmbH
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
state: RM
city: Massa
country: Italy
facility: Fondazione Toscana 'Gabriele Monasterio'
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Edinburgh
country: United Kingdom
facility: Edinburgh Heart Centre Royal Infirmary
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
References: