accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis - REBOOT-PARADOX (REBOOT-PARADOX)
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|ClinicalTrials.gov Identifier: NCT03863132|
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Device: TAVR||Not Applicable|
Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option.
Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well.
REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||783 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||December 2026|
Active Comparator: TAVR Group
Patients will be treated by transcatheter aortic valve repair (TAVR).
Repair of defective aortic valve by microsurgical Intervention.
No Intervention: Medical Treatment Group
Patients will receive optimal medical treatment alone.
- Time to death [ Time Frame: 24 months after last-patient-in ]All-cause mortality
- Cardiovascular mortality [ Time Frame: 5 years after index treatment ]Death because of cardiovascular events
- Re-hospitalization due to heart failure [ Time Frame: 5 years after index treatment ]Number of hospital stays after randomization
- Incidence of neurological events - incidence of strokes [ Time Frame: 5 years after randomization ]Number of strokes
- Incidence of neurological Events - incidence of transient ischaemic attacks [ Time Frame: 5 years after randomization ]Number of transient ischaemic attacks
- Cardiac functionality - left ventricular function [ Time Frame: 5 years after randomization ]Echocardiographic measurement of left ventricular ejection fraction in %
- Cardiac functionality - aortic valve hemodynamics [ Time Frame: 5 years after randomization ]Measurement of aortic pressure in mmHg
- Patients' quality of life [ Time Frame: 5 years after randomization ]EQ5D-score in %
- Device reliability [ Time Frame: 5 years after randomization ]Number of reinterventions (TAVR arm only)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863132
|Contact: Christoph Claas, Dr.||+49062159577 ext email@example.com|
|Contact: Marcel Kunadt, Dr.||+49062159577 ext firstname.lastname@example.org|
|Principal Investigator:||Julinda Mehilli, Prof. Dr.||University Clinic Munich|