Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-02 @ 9:29 AM
Study NCT ID:
NCT03863132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to death', 'timeFrame': '24 months after last-patient-in', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular mortality', 'timeFrame': '5 years after index treatment', 'description': 'Death because of cardiovascular events'}, {'measure': 'Re-hospitalization due to heart failure', 'timeFrame': '5 years after index treatment', 'description': 'Number of hospital stays after randomization'}, {'measure': 'Incidence of neurological events - incidence of strokes', 'timeFrame': '5 years after randomization', 'description': 'Number of strokes'}, {'measure': 'Incidence of neurological Events - incidence of transient ischaemic attacks', 'timeFrame': '5 years after randomization', 'description': 'Number of transient ischaemic attacks'}, {'measure': 'Cardiac functionality - left ventricular function', 'timeFrame': '5 years after randomization', 'description': 'Echocardiographic measurement of left ventricular ejection fraction in %'}, {'measure': 'Cardiac functionality - aortic valve hemodynamics', 'timeFrame': '5 years after randomization', 'description': 'Measurement of aortic pressure in mmHg'}, {'measure': "Patients' quality of life", 'timeFrame': '5 years after randomization', 'description': 'EQ5D-score in %'}, {'measure': 'Device reliability', 'timeFrame': '5 years after randomization', 'description': 'Number of reinterventions (TAVR arm only)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic stenosis', 'Low flow', 'Low gradient', 'Transcatheter aortic valve replacement'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nProbably 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.\n\nREBOOT-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years\n* 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\n* I3. Left ventricular ejection fraction ≥ 50%\n* 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)\n* I5. Heart team agrees on eligibility for TAVR\n* I6. Written informed consent\n* I7. Negative pregnancy test in women with childbearing potential\n\nExclusion Criteria:\n\n* E1. Hemodynamic instability\n* E2. Cardiogenic shock\n* E3. Pre-existing mechanical or bio-prosthetic valve in any position\n* E4. Concomitant severe valvular heart disease\n* E5. Pre-existing or active endocarditis\n* E6. Need for heart surgery due to other conditions\n* E7. Aortic valve is congenital unicuspid or congenital bicuspid\n* E8. Hypertrophic cardiomyopathy with or without obstruction\n* E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation\n* E10. Acute myocardial infarction within 1 month before intended AS-treatment\n* E11. Renal replacement therapy\n* E12. Estimated life expectancy \\< 24 months (730 days) due to carcinomas end stage liver disease or renal disease\n* 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.\n* E14. Patient refuses aortic valve repair'}, 'identificationModule': {'nctId': 'NCT03863132', 'acronym': 'REBOOT-PARADOX', 'briefTitle': 'accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'IHF GmbH - Institut für Herzinfarktforschung'}, 'officialTitle': 'Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison', 'orgStudyIdInfo': {'id': 'REBOOT-PARADOX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAVR Group', 'description': 'Patients will be treated by transcatheter aortic valve repair (TAVR).', 'interventionNames': ['Device: TAVR']}, {'type': 'NO_INTERVENTION', 'label': 'Medical Treatment Group', 'description': 'Patients will receive optimal medical treatment alone.'}], 'interventions': [{'name': 'TAVR', 'type': 'DEVICE', 'description': 'Repair of defective aortic valve by microsurgical Intervention.', 'armGroupLabels': ['TAVR Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der Universität München-Großhadern', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'overallOfficials': [{'name': 'Julinda Mehilli, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IHF GmbH - Institut für Herzinfarktforschung', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Group', 'class': 'UNKNOWN'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}