A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnteris Technologies Ltd.
About this trial
Prospective, randomized, controlled, multicenter, international study.
Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years.
After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'.
Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
Subject understands the study requirements and the treatment procedure and provides written informed consent.
Severe degeneration of a surgically implanted aortic bioprosthetic valve.
Disqualifiers
Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
Evidence of an acute myocardial infarction 30 days before randomization.
AV is unicuspid, Type 0 bicuspid, or is non-calcified.
Trial design
Design model
Parallel
Treatments tested in this trial
TAVR with DurAVR® THV
DeviceTranscatheter aortic valve replacement (TAVR)
TAVR with SAPIEN THV series or the Evolut THV series
DeviceTranscatheter aortic valve replacement (TAVR)
Treatment groups
1,650 Participants
are divided into 2 treatment groupsGroup A: DurAVR THVExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Time frame
1 YearSecondary outcomes
1
All-cause mortality
Mortality from any cause will by collected by tracking patient's living status via medical record
Time frame
30 Days2
Disabling stroke according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
30 Days3
Life-threatening bleeding according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
30 Days4
Major vascular complication according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame
30 DaysOther outcomes
1
Mean Aortic Valve (AV) Gradient
Mean Aortic Valve pressure gradient in mm Hg
Time frame
30 Days and 1 Year2
Valve-related dysfunction requiring a repeat procedure
New intervention due to the valve not properly functioning
Time frame
30 Days and 1 Year3
Doppler Velocity Index (DVI)
Doppler Velocity Index
Time frame
30 Days and 1 Year4
Non-Structural Valve Dysfunction
Any abnormality, not intrinsic to the prosthetic valve, resulting in the valve not properly functioning
Time frame
30 Days and 1 YearSponsors and contacts
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Source ClinicalTrials.gov