accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve… (NCT03863132) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Germany120 participantsStarted 2019-07-03
Plain-language summary
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
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:
* I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
* I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient \< 40 mmHg and stroke volume index (SVI) \< 35ml/m2
* I3. Left ventricular ejection fraction ≥ 50%
* I4. MDCT aortic valve calcium score men \> 2000AU, women \> 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age \< 70 yrs., AVS \< 0.8 cm2; SVI \< 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
* I5. Heart team agrees on eligibility for TAVR
* I6. Written informed consent
* I7. Negative pregnancy test in women with childbearing potential
Exclusion Criteria:
* E1. Hemodynamic instability
* E2. Cardiogenic shock
* E3. Pre-existing mechanical or bio-prosthetic valve in any position
* E4. Concomitant severe valvular heart disease
* E5. Pre-existing or active endocarditis
* E6. Need for heart surgery due to other conditions
* E7. Aortic valve is congenital unicuspid or congenital bicuspid
* E8. Hypertrophic cardiomyopathy with or without obstruction
* E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* E10. Acute myocardial infarction within 1 month before intended AS-treatment
* E11. Renal replacement therapy
* E12. Estimated life expectancy \< 24 months (730 days) due to carcinomas end stage liver disease or renal disease
* E13. Currently participating in an i…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Time to death
Timeframe: 24 months after last-patient-in
Trial details
NCT IDNCT03863132
SponsorIHF GmbH - Institut für Herzinfarktforschung