Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-04 @ 9:42 PM
Study NCT ID:
NCT02661451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-Cause Death', 'timeFrame': '12 months', 'description': 'Hierarchical occurrence within efficacy assessment time interval (EATI) of:'}, {'measure': 'Disabling Stroke', 'timeFrame': '12 months', 'description': 'Hierarchical occurrence within efficacy assessment time interval (EATI) of:'}, {'measure': 'Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).', 'timeFrame': '12 months', 'description': 'Hierarchical occurrence within efficacy assessment time interval (EATI) of:'}, {'measure': 'Change in KCCQ relative to baseline', 'timeFrame': '12 months', 'description': 'Hierarchical occurrence within efficacy assessment time interval (EATI) of:'}], 'secondaryOutcomes': [{'measure': 'MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of:', 'timeFrame': '12 month', 'description': '1. All-cause death\n2. Disabling stroke\n3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)'}, {'measure': '-All-cause death within EATI', 'timeFrame': '12 month', 'description': '-All-cause death within EATI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Valve'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '30704832', 'type': 'DERIVED', 'citation': 'Esquitin KA, Khalique OK, Liu Q, Kodali SK, Marcoff L, Nazif TM, George I, Vahl TP, Leon MB, Hahn RT. Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms. J Am Soc Echocardiogr. 2019 Mar;32(3):344-350. doi: 10.1016/j.echo.2018.11.018. Epub 2019 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nAll candidates for this study must meet all of the following inclusion criteria:\n\n1. Age ≥18 years\n2. Heart Failure with NYHA class ≥ 2\n3. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization.\n\n Note: Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for heart failure. (12, 13) Patients with aortic stenosis may not be able to tolerate maximal doses of heart failure medications and no specific guidelines exist for the medical treatment of heart failure in the setting of aortic stenosis. It is expected that the heart failure PI will review the medical therapy and confirm that it is appropriate for the patient's condition.\n4. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) \\>1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS is suspected when the an AVA \\> 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA\\<1.0 cm2 but with an indexed AVA of \\>0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients with AVA \\>1.5 cm2 but with indexed AVA\\<0.9 cm2/m2 on either rest of DSE are also eligible.\n\n Note: Typically such cases will demonstrate,\n\n • Mean trans-aortic gradient (MG) ≥ 20 mmHg and \\< 40 mmHg at rest and aortic valve area (AVA) \\> 1.0 cm2 and ≤1.5 cm2 (or AVA \\< 1.0 cm2 but indexed AVA \\> 0.6 cm2) at rest\n\n OR\n\n • Mean trans-aortic gradient (MG) ≥ 20 mmHg and \\< 40 mmHg and aortic valve area (AVA) ≤1.0 cm2 at rest AND MG \\< 40 mmHg and aortic valve area (AVA)\n\n •\\>1.0 cm2 (or AVA \\< 1.0 cm2 but indexed AVA \\> 0.6 cm2) with low dose dobutamine stress echo (DSE).\n\n In atypical cases (for example mean gradient is below 20 mmHg but valve area is consistent with moderate AS, the final eligibility determination in regards to diagnosis of moderate AS will be made by the echocardiographic core lab.\n5. Left ventricular (LV) ejection fraction (EF) \\< 50% at rest\n6. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV\n7. Able to provide independent informed consent (i.e., not requiring a legally authorized representative)\n\nExclusion Criteria\n\nCandidates are excluded from the study if any of the following conditions are present:\n\n1. LVEF \\< 20% or persistent need for intravenous inotropic support\n2. Hospitalization for acute decompensated HF within 2 weeks prior to randomization\n3. Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization\n4. Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization\n5. In need and suitable for revascularization per heart team consensus\n6. Severe aortic and/or mitral regurgitation\n7. Congenital unicuspid or congenital bicuspid aortic valve\n8. Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA)\n9. Previous aortic valve replacement (mechanical or bioprosthetic)\n10. Severe RV dysfunction\n11. Previous stroke with permanent disability (modified Rankin score ≥ 2)\n12. Severe lung disease as indicated by FEV1 \\<30% predicted or need for chronic daytime supplemental oxygen therapy\n13. Severe chronic kidney disease: glomerular filtration rate (GFR) \\< 30 mL/min by MDRD or need for renal replacement therapy\n14. Gastrointestinal (GI) bleeding within the past 3 months\n15. Liver cirrhosis Child-Pugh C\n16. Active systemic infection, including active endocarditis\n17. Unwilling to accept blood transfusion\n18. Evidence of intracardiac mass, thrombus or vegetation\n19. Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV\n20. Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation)\n21. Sensitivity to contrast media which cannot be adequately pre-medicated\n22. Women of child-bearing potential\n23. Clinical signs of dementia\n24. Other medical, social, or psychological conditions that precludes appropriate consent and follow-up\n25. Life expectancy \\< 2 years due to cancer or other non-cardiac chronic diseases\n26. Unwillingness to undergo follow-up investigations\n27. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries)"}, 'identificationModule': {'nctId': 'NCT02661451', 'briefTitle': 'Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)', 'organization': {'class': 'OTHER', 'fullName': 'Cardiovascular Research Foundation, New York'}, 'officialTitle': 'Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)', 'orgStudyIdInfo': {'id': 'TAVR Unload'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAVR (with SAPIEN 3 THV) and OHFT', 'description': 'Transcatheter heart valve and Optimal Heart Failure Therapy', 'interventionNames': ['Device: SAPIEN 3 THV', 'Biological: Optimal Heart Failure Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OHFT', 'description': 'Optimal Heart Failure Therapy', 'interventionNames': ['Biological: Optimal Heart Failure Therapy']}], 'interventions': [{'name': 'SAPIEN 3 THV', 'type': 'DEVICE', 'armGroupLabels': ['TAVR (with SAPIEN 3 THV) and OHFT']}, {'name': 'Optimal Heart Failure Therapy', 'type': 'BIOLOGICAL', 'armGroupLabels': ['OHFT', 'TAVR (with SAPIEN 3 THV) and OHFT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chandler Regional Medical Center', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD/Sulpizio Cardiovascular Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80538', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medical Center of the Rockies', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medstar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '60453', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '60210', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Hospital/NorthShore Univ. Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Hospital', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation Hospital', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48072', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': "Ascension St. Mary's Hospital", 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthEast Medical Research Institute', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': 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Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Clinics', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiovascular Research Foundation, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardialysis BV', 'class': 'INDUSTRY'}, {'name': 'Avania', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}