Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Aortic Valve Stenosis Clinical Trial

— ECHOCATH  

Official title:

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459233
• Other study ID #: ECHOCATH
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: September 1, 2029

Study information

• Verified date: December 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Josep Rodés-Cabau, MD
• Phone: 418-656-8711
• Email: josep.rodes[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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,

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation
• Aortic Valve Stenosis
• Prosthesis Failure

Intervention

Procedure:
• Doppler-echocardiography
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.
• Invasive hemodynamic measurements
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.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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

Outcome

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