Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-09 @ 7:44 AM
Study NCT ID:
NCT05459233
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}, {'id': 'D011475', 'term': 'Prosthesis Failure'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blinded trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 fashion to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Quality of life (Efficacy)', 'timeFrame': '12 months follow-up', 'description': 'Change in quality of life as evaluated by the Kansas City Cardiomyopathy Questionnaire (KCCQ). All score are represented on a 0-to-100-point scale (lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.'}, {'measure': 'Periprocedural complications (Safety)', 'timeFrame': 'Periprocedural', 'description': 'Periprocedural complications including in-hospital mortality, stroke, annular rupture, coronary obstruction, new-onset left bundle branch block, need for permanent pacemaker implantation and conversion to open heart surgery.'}], 'secondaryOutcomes': [{'measure': 'Residual transvalvular gradient', 'timeFrame': '1 month and 12 months follow-up', 'description': 'Residual (maximal and mean) transvalvular gradient'}, {'measure': 'Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance)', 'timeFrame': '1 month and 12 months follow-up', 'description': 'Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).'}, {'measure': 'Heart failure', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'Evaluated by the New York Heart Association (NYHA) Functional Classification'}, {'measure': 'Exercise capacity', 'timeFrame': '1 month and 12 months follow-up', 'description': 'Exercise capacity as evaluated by the six-minute wlak test.'}, {'measure': 'Changes in Quality of life', 'timeFrame': 'after 1-year follow-up (yearly up to 5 years)', 'description': 'severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life).The KCCQ is a 7 domains questionnaire; symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy.'}, {'measure': 'Clinical safety endpoints', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'Individually and combined: death, stroke, major of lifethreatening bleeding, pacemaker implantation, myocardial infarction'}, {'measure': 're-hospitalization', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'Need for re-hospitalization'}, {'measure': 'wear and tear deterioration (Structural valve degeneration)', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'wear and tear evaluated by echocardiography imaging'}, {'measure': 'Leaflet disruption (Structural valve degeneration)', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'leaflet disruption evaluated by echocardiography imaging'}, {'measure': 'flail leaflet (Structural valve degeneration)', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'flail leaflet evaluated by echocardiography imaging'}, {'measure': 'leaflet fibrosis and/or calcification (Structural valve degeneration)', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'leaflet fibrosis and/or calcification evaluated by echocardiography imaging'}, {'measure': 'strut fracture or deformation (Structural valve degeneration)', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'strut fracture or deformation evaluated by echocardiography imaging'}, {'measure': 'Valve re-intervention', 'timeFrame': '1 and 12 months follow-up and yearly up to 5 years', 'description': 'Need for valve re-intervention'}, {'measure': 'Changes in Left ventricle mass', 'timeFrame': '1-month and 1-year follow-up', 'description': 'Changes in LV mass'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis', 'Aortic Valve Regurgitation', 'Prosthesis Failure']}, 'referencesModule': {'references': [{'pmid': '26516006', 'type': 'BACKGROUND', 'citation': 'Paradis JM, Del Trigo M, Puri R, Rodes-Cabau J. Transcatheter Valve-in-Valve and Valve-in-Ring for Treating Aortic and Mitral Surgical Prosthetic Dysfunction. J Am Coll Cardiol. 2015 Nov 3;66(18):2019-2037. doi: 10.1016/j.jacc.2015.09.015.'}, {'pmid': '33888385', 'type': 'BACKGROUND', 'citation': 'VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.'}, {'pmid': '25005653', 'type': 'BACKGROUND', 'citation': 'Dvir D, Webb JG, Bleiziffer S, Pasic M, Waksman R, Kodali S, Barbanti M, Latib A, Schaefer U, Rodes-Cabau J, Treede H, Piazza N, Hildick-Smith D, Himbert D, Walther T, Hengstenberg C, Nissen H, Bekeredjian R, Presbitero P, Ferrari E, Segev A, de Weger A, Windecker S, Moat NE, Napodano M, Wilbring M, Cerillo AG, Brecker S, Tchetche D, Lefevre T, De Marco F, Fiorina C, Petronio AS, Teles RC, Testa L, Laborde JC, Leon MB, Kornowski R; Valve-in-Valve International Data Registry Investigators. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014 Jul;312(2):162-70. doi: 10.1001/jama.2014.7246.'}, {'pmid': '32592401', 'type': 'BACKGROUND', 'citation': 'Bleiziffer S, Simonato M, Webb JG, Rodes-Cabau J, Pibarot P, Kornowski R, Windecker S, Erlebach M, Duncan A, Seiffert M, Unbehaun A, Frerker C, Conzelmann L, Wijeysundera H, Kim WK, Montorfano M, Latib A, Tchetche D, Allali A, Abdel-Wahab M, Orvin K, Stortecky S, Nissen H, Holzamer A, Urena M, Testa L, Agrifoglio M, Whisenant B, Sathananthan J, Napodano M, Landi A, Fiorina C, Zittermann A, Veulemans V, Sinning JM, Saia F, Brecker S, Presbitero P, De Backer O, Sondergaard L, Bruschi G, Franco LN, Petronio AS, Barbanti M, Cerillo A, Spargias K, Schofer J, Cohen M, Munoz-Garcia A, Finkelstein A, Adam M, Serra V, Teles RC, Champagnac D, Iadanza A, Chodor P, Eggebrecht H, Welsh R, Caixeta A, Salizzoni S, Dager A, Auffret V, Cheema A, Ubben T, Ancona M, Rudolph T, Gummert J, Tseng E, Noble S, Bunc M, Roberts D, Kass M, Gupta A, Leon MB, Dvir D. Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves. Eur Heart J. 2020 Aug 1;41(29):2731-2742. doi: 10.1093/eurheartj/ehaa544.'}, {'pmid': '30354588', 'type': 'BACKGROUND', 'citation': 'de Freitas Campos Guimaraes L, Urena M, Wijeysundera HC, Munoz-Garcia A, Serra V, Benitez LM, Auffret V, Cheema AN, Amat-Santos IJ, Fisher Q, Himbert D, Garcia Del Blanco B, Dager A, Le Breton H, Paradis JM, Dumont E, Pibarot P, Rodes-Cabau J. Long-Term Outcomes After Transcatheter Aortic Valve-in-Valve Replacement. Circ Cardiovasc Interv. 2018 Sep;11(9):e007038. doi: 10.1161/CIRCINTERVENTIONS.118.007038.'}, {'pmid': '30003366', 'type': 'BACKGROUND', 'citation': 'Wernly B, Zappe AK, Unbehaun A, Sinning JM, Jung C, Kim WK, Fichtlscherer S, Lichtenauer M, Hoppe UC, Alushi B, Beckhoff F, Wewetzer C, Franz M, Kretzschmar D, Navarese E, Landmesser U, Falk V, Lauten A. Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves. Clin Res Cardiol. 2019 Jan;108(1):83-92. doi: 10.1007/s00392-018-1326-z. Epub 2018 Jul 12.'}, {'pmid': '31146808', 'type': 'BACKGROUND', 'citation': 'Webb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.'}, {'pmid': '34003666', 'type': 'BACKGROUND', 'citation': 'Kaneko T, Makkar RR, Krishnaswami A, Hermiller J, Greenbaum A, Babaliaros V, Shah PB, Bailey SH, Bapat V, Kapadia S, Abbas AE. Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality. Circ Cardiovasc Interv. 2021 May;14(5):e010288. doi: 10.1161/CIRCINTERVENTIONS.120.010288. Epub 2021 May 18.'}, {'pmid': '29593832', 'type': 'BACKGROUND', 'citation': 'Saxon JT, Allen KB, Cohen DJ, Chhatriwalla AK. Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside. Interv Cardiol. 2018 Jan;13(1):20-26. doi: 10.15420/icr.2017:29:1.'}, {'pmid': '31867060', 'type': 'BACKGROUND', 'citation': "O'Donnell JP, O'Sullivan CJ. Bioprosthetic Aortic Valve Fracture During Valve-in-valve Transcatheter Aortic Valve Implantation. Interv Cardiol. 2019 Nov 18;14(3):147-151. doi: 10.15420/icr.2019.08.R2. eCollection 2019 Nov."}]}, 'descriptionModule': {'briefSummary': 'Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between echocardiography and catheterization, with an overestimation of the real gradient with echo (vs. cath) in most cases. Thus, the incidence of procedural-device failure may be lower than that reported in the ViV-TAVR literature,', 'detailedDescription': "This is a prospective, multicenter, randomized, single-blinded design trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical bioprosthesis with a labeled size ≤25 mm. Following the Heart Team's decision to proceed with a ViV-TAVR procedure with the SAPIEN 3 ULTRA valve (or its subsequent iterations), patients will be randomized to valve hemodynamic optimization according to Doppler-echocardiography versus cardiac catheterization parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team\n* Surgical stented bioprosthetic valve (label size ≤25 mm)\n* TAVR with the SAPIEN 3 Ultra valve\n\nExclusion Criteria:\n\n* Stentless or sutureless surgical valves\n* Trifecta bioprosthesis\n* Hancock II bioprosthesis\n* High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \\<4 mm or based on the criterion of the heart team responsible for the procedure).\n* Impossibility to obtain written informed consent'}, 'identificationModule': {'nctId': 'NCT05459233', 'acronym': 'ECHOCATH', 'briefTitle': 'Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR', 'organization': {'class': 'OTHER', 'fullName': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}, 'officialTitle': 'Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'ECHOCATH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Doppler-echocardiography', 'description': 'Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements.', 'interventionNames': ['Procedure: Doppler-echocardiography']}, {'type': 'OTHER', 'label': 'Invasive hemodynamic measurements', 'description': 'Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording).', 'interventionNames': ['Procedure: Invasive hemodynamic measurements']}], 'interventions': [{'name': 'Doppler-echocardiography', 'type': 'PROCEDURE', 'description': 'The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further intervention will be based on Doppler-echocardiographic measurements. Balloon post-dilation with a non-compliant balloon will be performed in the presence of a residual mean gradient ≥20 mmHg as assessed by Doppler-echocardiography.', 'armGroupLabels': ['Doppler-echocardiography']}, {'name': 'Invasive hemodynamic measurements', 'type': 'PROCEDURE', 'description': 'The TAVR (valve-in-valve) procedure will be performed with the SAPIEN 3 Ultra valve, with valve sizing according to current manufacturer recommendations. Following valve implantation, further interventions will be based on invasive hemodynamic measurements (with simultaneous aortic and ventricular pressure recording). Balloon post-dilation will be performed with a non-compliant balloon in the presence of a mean residual gradient ≥20 mmHg as assessed by hemodynamic measurements.', 'armGroupLabels': ['Invasive hemodynamic measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sammy Elmariah', 'role': 'CONTACT'}, {'name': 'Mallika Saxena', 'role': 'CONTACT', 'email': 'Mallika.Saxena@ucsf.edu'}], 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Houman Khalili', 'role': 'CONTACT'}, {'name': 'Hina Khan', 'role': 'CONTACT', 'email': 'hikhan@mhs.net'}], 'facility': 'South Broward Hospital Disctrict D/B/A Memorial Healthcare System', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amr Abbas', 'role': 'CONTACT'}, {'name': 'Lauren Scribner', 'role': 'CONTACT', 'email': 'Lauren.Scribner@corewellhealth.org'}], 'facility': 'William Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mackram F Eleid, M.D.', 'role': 'CONTACT'}, {'name': 'Tricia A', 'role': 'CONTACT', 'email': 'conley.tricia@mayo.edu', 'phone': '(507) 422-3897'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '13203', 'city': 'Syracuse', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ayman Iskander', 'role': 'CONTACT'}, {'name': 'Laura Mowers', 'role': 'CONTACT', 'email': 'laura.mowers@sjhcardiology.org'}], 'facility': "St-Joseph's Health INC", 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Santiago Garcia, M.D.', 'role': 'CONTACT'}, {'name': 'Susan Reilly', 'role': 'CONTACT', 'email': 'Susan.Reilly@thechristhospital.com', 'phone': '513-585-2165'}], 'facility': 'The Christ Hospital Health Network', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Josep Rodes-Cabau, MD', 'role': 'CONTACT', 'email': 'josep.rodes@criucpq.ulaval.ca', 'phone': '418-656-8711'}, {'name': 'Emilie Pelletier Beaumont, MSc', 'role': 'CONTACT', 'email': 'emilie.pelletier-beaumont@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3929'}, {'name': 'Josep Rodes-Cabau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Josep Rodés-Cabau, MD', 'role': 'CONTACT', 'email': 'josep.rodes@criucpq.ulaval.ca', 'phone': '418-656-8711'}, {'name': 'Emilie Pelletier Beaumont, MSc', 'role': 'CONTACT', 'email': 'emilie.pelletier-beaumont@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3929'}], 'overallOfficials': [{'name': 'Josep Rodés-Cabau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Josep Rodes-Cabau', 'investigatorAffiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}}}}