TIARA-II
Research type
Research Study
Full title
Tiara™ Transcatheter Mitral Valve Replacement Study (TIARA-II)
IRAS ID
218597
Contact name
Olaf Wendler
Contact email
Sponsor organisation
Neovasc Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 4 months, 1 days
Research summary
Research Summary:
More than 50% of patients with severe Mitral Regurgitation (MR) who are potential candidates for surgery are denied this opportunity, most often due to comorbid conditions, advanced age, or impaired heart function. Transcatheter Mitral Valve Replacement (TMVR) with the Neovasc Tiara valve may be a treatment option for this patient population.
As of 17 February 2017, there have been a total of 24 patients implanted with Tiara mitral valves. While long term outcomes are not available for all patients, the longest patient follow up is at 3 years.
Therefore, this prospective study (called TIARA-II) will enroll 115 subjects who have high risk for surgery and may benefit from implantation of the Tiara valve, based on precise inclusion and exclusion criteria derived from the latest scientific guidelines. The study will include centralized screening and selection of the patients, careful monitoring by both a Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC), and annual reports for continued assessment of safety and performance.
Summary of Results:
Results include subjects who underwent implantation of the Tiara valve. The primary safety endpoint is analyzed on the intent-to-treat population. All partial data available for subjects who dropped out during the course of the study were included. If there was incomplete data for any subjects in the intent-to-treat population, the Kaplan-Meier method was used so that this partial data was include.
The primary safety endpoint is freedom from all-cause mortality and major adverse events defined as disabling stroke, myocardial infarction (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention at 30 days from the implant procedure or hospital discharge, whichever is later. Freedom from all-cause mortality and major adverse events through 30 days was 64.7%. Table 7 contains results from 0 days through 30 days.
The primary efficacy endpoint is the reduction of MR to optimal or acceptable at 30 days. MR reduction is considered optimal when post-procedure MR is reduced to trace or absent. MR reduction is considered acceptable when post-procedure MR is reduced by at least one class or grade from baseline and to no more than moderate (2+) in severity. Table 8 demonstrates the reduction in MR at 30 Days compared to Baseline. Thiry-four subjects underwent implant, but 23 were assessed for MR at 30 days since 7 subjects were exited prior to 30 days (3 for removal of the Tiara valve and 4 died. An additional two subjects were eligible for the 30 day visit but did not attend.
Freedom from all-cause mortality and major adverse events after 30 days and through 5 years is given in Table 9 of the Final Report. Individual components of the primary endpoint at 30 days from implant through 5 years are also included in Table 9 as a secondary endpoint analysis. These individual components include: disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, cardiac surgical reintervention or cardiac transcatheter reintervention.
Clinical performance is assessed at follow-up intervals from 30 days through 5 years compared to Baseline for NYHA Functional Class, 6MWT and KCCQ. Hemodynamic performance is assessed by echocardiography including mean MV gradient, mitral regurgitation, and effective orifice area of MV.
Eighteen subjects were eligible for the one-year follow-up visit, and of these, 16 subjects completed that visit. NYHA was improved from baseline to one year with a mean of 2.8 at baseline and a mean of 1.9 at one year (Table 11 of the final report). 6MWT also improved from a mean of 269.9 at baseline and a mean of 258.4 at one year (Table 12 of the final report). KCCQ improved from a mean of 53.2 at baseline to a mean of 70.3 at one year (Table 13 of the final report).
There have been no Unanticipated Adverse Device Effects (UADEs) reported or adjudicated for this study.
A total of 73 serious adverse events have been adjudicated from day of procedure through final data cut-off (Table 16 of the final report). A listing of all adjudicated events (from time of consent through data cut-off) can be found in Appendix 2. of the final report.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0229
Date of REC Opinion
27 Jul 2017
REC opinion
Further Information Favourable Opinion