Aortic Valve Stenosis Clinical Trial
— ECHOCATHOfficial title:
Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial
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,
Status | Recruiting |
Enrollment | 310 |
Est. completion date | September 1, 2029 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Surgical stented bioprosthetic valve (label size =25 mm) - TAVR with the SAPIEN 3 Ultra valve Exclusion Criteria: - Stentless or sutureless surgical valves - Trifecta bioprosthesis - Hancock II bioprosthesis - 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). - Impossibility to obtain written informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | IUCPQ | Quebec |
Lead Sponsor | Collaborator |
---|---|
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval |
Canada,
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. — View 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. — View 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. — View 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. Erratum In: Circ Cardiovasc Interv. 2021 Jul;14(7):e000083. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Clin Res Cardiol. 2018 Sep 4;: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Quality of life (Efficacy) | 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. | 12 months follow-up | |
Primary | Periprocedural complications (Safety) | 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. | Periprocedural | |
Secondary | Residual transvalvular gradient | Residual (maximal and mean) transvalvular gradient | 1 month and 12 months follow-up | |
Secondary | Combined enpoint: Moderate or severe prothesis-patient mismatch and/or moderate or severe aortic regurgitation (valve performance) | 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). | 1 month and 12 months follow-up | |
Secondary | Heart failure | Evaluated by the New York Heart Association (NYHA) Functional Classification | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | Exercise capacity | Exercise capacity as evaluated by the six-minute wlak test. | 1 month and 12 months follow-up | |
Secondary | Changes in Quality of life | 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. | after 1-year follow-up (yearly up to 5 years) | |
Secondary | Clinical safety endpoints | Individually and combined: death, stroke, major of lifethreatening bleeding, pacemaker implantation, myocardial infarction | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | re-hospitalization | Need for re-hospitalization | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | wear and tear deterioration (Structural valve degeneration) | wear and tear evaluated by echocardiography imaging | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | Leaflet disruption (Structural valve degeneration) | leaflet disruption evaluated by echocardiography imaging | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | flail leaflet (Structural valve degeneration) | flail leaflet evaluated by echocardiography imaging | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | leaflet fibrosis and/or calcification (Structural valve degeneration) | leaflet fibrosis and/or calcification evaluated by echocardiography imaging | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | strut fracture or deformation (Structural valve degeneration) | strut fracture or deformation evaluated by echocardiography imaging | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | Valve re-intervention | Need for valve re-intervention | 1 and 12 months follow-up and yearly up to 5 years | |
Secondary | Changes in Left ventricle mass | Changes in LV mass | 1-month and 1-year follow-up |
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