Aortic Valve Stenosis Clinical Trial
— REBOOT-PARADOXOfficial 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
Verified date | March 2024 |
Source | IHF GmbH - Institut für Herzinfarktforschung |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | March 1, 2028 |
Est. primary completion date | September 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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. - E14. Patient refuses aortic valve repair |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum der Universität München-Großhadern | München | Bayern |
Lead Sponsor | Collaborator |
---|---|
IHF GmbH - Institut für Herzinfarktforschung | Boston Scientific Group, Yale University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to death | All-cause mortality | 24 months after last-patient-in | |
Secondary | Cardiovascular mortality | Death because of cardiovascular events | 5 years after index treatment | |
Secondary | Re-hospitalization due to heart failure | Number of hospital stays after randomization | 5 years after index treatment | |
Secondary | Incidence of neurological events - incidence of strokes | Number of strokes | 5 years after randomization | |
Secondary | Incidence of neurological Events - incidence of transient ischaemic attacks | Number of transient ischaemic attacks | 5 years after randomization | |
Secondary | Cardiac functionality - left ventricular function | Echocardiographic measurement of left ventricular ejection fraction in % | 5 years after randomization | |
Secondary | Cardiac functionality - aortic valve hemodynamics | Measurement of aortic pressure in mmHg | 5 years after randomization | |
Secondary | Patients' quality of life | EQ5D-score in % | 5 years after randomization | |
Secondary | Device reliability | Number of reinterventions (TAVR arm only) | 5 years after randomization |
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