RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH… (NCT05036018) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
Germany836 participantsStarted 2021-08-30
Plain-language summary
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
* Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
* Heart team consensus that the patient is anatomically suitable for both device types
* Suitability for transfemoral vascular access
* Written informed consent
Exclusion Criteria:
* Life expectancy \<12 months due to comorbidities
* Native aortic valve annulus \<21 mm and \>27 mm
* Bicuspid aortic valve
* Cardiogenic shock or hemodynamic instability
* Active endocarditis
* Contraindications for transfemoral access
* Active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks
* Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
* Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
* Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
* Active infection requiring antibiotic treatment
* Age \<18 years
* Participation in another interventional trial where the primary endpoint has not been reached
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing newer self-expanding heart valves against each other, as well as a 'minimalist' procedure approach against standard care — given my specific anatomy and health history, does my doctor think one of these valve types or approaches would be more appropriate for me, and how does what this trial is studying relate to that decision?
2The trial is tracking serious outcomes at 30 days including death, stroke, a pacemaker being needed, and how well the valve seals — what is my doctor's honest assessment of my personal risk for each of those outcomes based on my current condition?
3Since this study is no longer enrolling new patients, it won't be an option for me to join — but can my doctor tell me whether the 'minimalist' approach being studied here, which aims to simplify the TAVI procedure, is something already available to me at this center or through another program?
4The trial is measuring vascular and bleeding complications using a specific grading system called VARC-3 — can my doctor explain what the most common vascular or bleeding risks look like in practice for someone like me undergoing TAVI, and how those risks compare between a minimalist and a standard approach?
5Because this trial is in a late active phase but not yet reporting final results, should I ask about waiting for the published outcomes before making a decision, or would delaying my aortic stenosis treatment carry risks that outweigh the benefit of having that additional information?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
Timeframe: Day 30
2
Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)