A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

Official title

A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices

Overview

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.

Interventions

• Device TAVR with DurAVR® THV
  Transcatheter aortic valve replacement (TAVR)
• Device TAVR with SAPIEN THV series or the Evolut THV series
  Transcatheter aortic valve replacement (TAVR)

Primary outcome measures

• Composite of all-cause mortality, all stroke and cardiovascular hospitalization [Time frame: 1 Year]

Secondary outcome measures (5)

• All-cause mortality [Time frame: 30 Days]
• Disabling stroke according to VARC-3 Guidelines [Time frame: 30 Days]
• Life-threatening bleeding according to VARC-3 Guidelines [Time frame: 30 Days]
• Major vascular complication according to VARC-3 Guidelines [Time frame: 30 Days]
• Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines [Time frame: 30 Days]

Eligibility criteria

Inclusion criteria

Native Aortic Stenosis Cohorts:

• 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.

ViV Registry Cohort:

• Severe degeneration of a surgically implanted aortic bioprosthetic valve.
• Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
• Subject understands the study requirements and the treatment procedure and provides written informed consent.

Exclusion criteria

Native Aortic Stenosis Cohorts:

• 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.
• Severe total aortic regurgitation
• Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
• Pre-existing mechanical or bioprosthetic valve in any position.
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
• Active bacterial endocarditis in the last 3 months.
• Estimated life expectancy (after TAVR) <12 months.
• Subject is not a candidate for both arms (investigational and control) of the study.
• Subject belongs to a vulnerable population

ViV Registry Cohort:

• Anatomy precluding safe placement of DurAVR THV.
• Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
• Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
• Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
• Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
• Need for emergency surgery for any reason
• GI bleeding within the past 3 months.
• Active bacterial endocarditis in the last 3 months.
• Estimated life expectancy (after TAVR) <12 months.
• Subject belongs to a vulnerable population.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07194265 · SP0083

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗