Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement.

Transcatheter Aortic Valve Replacement Clinical Trial

— PROMOTE  

Official title:

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139616
• Other study ID #: PROMOTE
• Status: Recruiting
• Start date: February 25, 2020
• Est. completion date: February 25, 2025

Study information

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

Clinical Trial Summary

The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of a large proportion of such patients. The implementation of a pre-specified treatment strategy translating into a more uniform practice regarding the management of conduction disturbances post-TAVR applied to a large cohort of patients would permit to identify the benefits and drawbacks of each specific aspect of the treatment algorithm proposal. This may also help to improve both the management and clinical outcomes of the complex group of patients with conduction disturbances associated with TAVR. In the end, the final objective of a pre-specified strategy for managing conduction disturbances post-TAVR should be to obtain a low rate of PPM without increasing the risk of sudden death or life threatening arrhythmic events following hospital discharge, and all this while avoiding an excessive prolongation of the hospitalization period following the TAVR procedure.

Description:

The objectives of the study are: - Feasibility: to validate and determine the applicability of a pre-specified algorithm for managing conduction disturbances in consecutive patients undergoing TAVR, also evaluating the percentage of patients included in each group of the algorithm strategy. - Efficacy: (i) to evaluate the rate of permanent pacemaker implantation in-hospital and at 30 days compared to that of the year prior to the implementation of the protocol, (ii) to determine the incidence of sudden death at 30 days and at 1-year follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 25, 2025
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Patients with aortic valve disease undergoing transcatheter aortic valve replacement

Exclusion Criteria:

• Prior permanent pacemaker
• Failure to provide signed informed consent for data collection
• Impossibility for a follow-up
• Unwillingness to follow the pre-specified strategy for the management of conduction disturbances

Related Conditions & MeSH terms

• Conduction Disturbances
• Permanent Pacemaker Implantation
• Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Auffret V, Lefevre T, Van Belle E, Eltchaninoff H, Iung B, Koning R, Motreff P, Leprince P, Verhoye JP, Manigold T, Souteyrand G, Boulmier D, Joly P, Pinaud F, Himbert D, Collet JP, Rioufol G, Ghostine S, Bar O, Dibie A, Champagnac D, Leroux L, Collet F, Teiger E, Darremont O, Folliguet T, Leclercq F, Lhermusier T, Olhmann P, Huret B, Lorgis L, Drogoul L, Bertrand B, Spaulding C, Quilliet L, Cuisset T, Delomez M, Beygui F, Claudel JP, Hepp A, Jegou A, Gommeaux A, Mirode A, Christiaens L, Christophe C, Cassat C, Metz D, Mangin L, Isaaz K, Jacquemin L, Guyon P, Pouillot C, Makowski S, Bataille V, Rodes-Cabau J, Gilard M, Le Breton H; FRANCE TAVI Investigators. Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI. J Am Coll Cardiol. 2017 Jul 4;70(1):42-55. doi: 10.1016/j.jacc.2017.04.053. — View Citation

Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352. — View Citation

Cerrato E, Nombela-Franco L, Nazif TM, Eltchaninoff H, Sondergaard L, Ribeiro HB, Barbanti M, Nietlispach F, De Jaegere P, Agostoni P, Trillo R, Jimenez-Quevedo P, D'Ascenzo F, Wendler O, Maluenda G, Chen M, Tamburino C, Macaya C, Leon MB, Rodes-Cabau J. Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey. Int J Cardiol. 2017 Feb 1;228:640-647. doi: 10.1016/j.ijcard.2016.11.104. Epub 2016 Nov 9. — View Citation

Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255. — View Citation

Kolte D, Vlahakes GJ, Palacios IF, Sakhuja R, Passeri JJ, Inglessis I, Elmariah S. Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol. 2019 Sep 24;74(12):1532-1540. doi: 10.1016/j.jacc.2019.06.076. — View Citation

Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):932-987. doi: 10.1016/j.jacc.2018.10.043. Epub 2018 Nov 6. No abstract available. Erratum In: J Am Coll Cardiol. 2019 Aug 20;74(7):1014-1016. — View Citation

Puri R, Chamandi C, Rodriguez-Gabella T, Rodes-Cabau J. Future of transcatheter aortic valve implantation - evolving clinical indications. Nat Rev Cardiol. 2018 Jan;15(1):57-65. doi: 10.1038/nrcardio.2017.116. Epub 2017 Aug 24. — View Citation

Rodes-Cabau J, Ellenbogen KA, Krahn AD, Latib A, Mack M, Mittal S, Muntane-Carol G, Nazif TM, Sondergaard L, Urena M, Windecker S, Philippon F. Management of Conduction Disturbances Associated With Transcatheter Aortic Valve Replacement: JACC Scientific Expert Panel. J Am Coll Cardiol. 2019 Aug 27;74(8):1086-1106. doi: 10.1016/j.jacc.2019.07.014. — View Citation

van Rosendael PJ, Delgado V, Bax JJ. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review. Eur Heart J. 2018 Jun 1;39(21):2003-2013. doi: 10.1093/eurheartj/ehx785. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm		1 year follow-up
Primary	Incidence of permanent pacemaker implantation		At 30-day follow-up
Primary	Incidence of permanent pacemaker implantation		At 1-year follow-up
Primary	Incidence of sudden death		At 30-day follow-up
Primary	Incidence of sudden death		At 1-year follow-up
Secondary	Rate, timing of and reasons for permanent pacemaker implantation	Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm	Before hospital discharge (between 1 to 30 days)
Secondary	Rate, timing of and reasons for permanent pacemaker implantation	Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm	At 30-day follow-up
Secondary	Rate, timing of and reasons for permanent pacemaker implantation	Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm	At 1 year follow-up
Secondary	Rate and timing of sudden death	Rate and timing of sudden death in each group of the pre-specified algorithm	At 30-day follow-up
Secondary	Rate and timing of sudden death	Rate and timing of sudden death in each group of the pre-specified algorithm	At 1-year follow-up
Secondary	Evaluation of arrhythmic events in patients with continuous ECG monitoring	Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge	After hospital discharge (up to 1-year)
Secondary	Evaluation of the rate and timing of permanent pacemaker implantation		After hospital discharge (up to 1-year)
Secondary	Rate of PPI among valve types	Compare rate of permanent pacemaker implantation among different valve types	At 30-day follow-up
Secondary	Rate of PPI among valve types	Compare rate of permanent pacemaker implantation among different valve types	At 1-year follow-up
Secondary	Pace dependency and pacing rate	Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)	At 30-day follow-up
Secondary	Pace dependency and pacing rate	Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)	At 1-year follow-up
Secondary	Factors associated with sudden death or permanent pacemaker implantation	Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group	At 30-day follow-up
Secondary	Factors associated with sudden death or permanent pacemaker implantation	Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group	At 1-year follow-up