Active, not recruitingNo phase
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Key facts
- Who runs it
- IHF GmbH - Institut für Herzinfarktforschung
- Where
- Germany, Italy, and Switzerland15 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 120 people enrolled
- Started
- 3 Jul 2019
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TAVR
- Record updated
- 9 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- E4. Concomitant severe valvular heart disease
- E10. Acute myocardial infarction within 1 month before intended AS-treatment
- E11. Renal replacement therapy
- E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials
- E6. Need for heart surgery due to other conditions
- E12. Estimated life expectancy < 24 months (730 days) due to carcinomas end stage liver disease or renal disease
- E1. Hemodynamic instability
- E2. Cardiogenic shock
- E3. Pre-existing mechanical or bio-prosthetic valve in any position
- E5. Pre-existing or active endocarditis
- 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
- E14. Patient refuses aortic valve repair
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- TAVR GroupExisting treatment, for comparison
Patients will be treated by transcatheter aortic valve repair (TAVR).
Treatment: TAVR
- Medical Treatment GroupNo study treatment, for comparison
Patients will receive optimal medical treatment alone.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison
- Publications
- Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis: REBOOT-PARADOX.Journal of the American College of Cardiology, 2026
- Record updated
- 9 November 2026