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Tests treatment safety and results for Severe Aortic Stenosis
Official title A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
ClinicalTrials.gov ID: NCT07194265
What this study is testing
- What it's testing
- 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'.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region of Denmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region of Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.