Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm [Срок оценки: 1 year follow-up]
• Incidence of permanent pacemaker implantation [Срок оценки: At 30-day follow-up]
• Incidence of permanent pacemaker implantation [Срок оценки: At 1-year follow-up]
• Incidence of sudden death [Срок оценки: At 30-day follow-up]
• Incidence of sudden death [Срок оценки: At 1-year follow-up]

Вторичные конечные точки (12)

• Rate, timing of and reasons for permanent pacemaker implantation [Срок оценки: Before hospital discharge (between 1 to 30 days)]
• Rate, timing of and reasons for permanent pacemaker implantation [Срок оценки: At 30-day follow-up]
• Rate, timing of and reasons for permanent pacemaker implantation [Срок оценки: At 1 year follow-up]
• Rate and timing of sudden death [Срок оценки: At 30-day follow-up]
• Rate and timing of sudden death [Срок оценки: At 1-year follow-up]
• Evaluation of arrhythmic events in patients with continuous ECG monitoring [Срок оценки: After hospital discharge (up to 1-year)]
• Evaluation of the rate and timing of permanent pacemaker implantation [Срок оценки: After hospital discharge (up to 1-year)]
• Rate of PPI among valve types [Срок оценки: At 30-day follow-up]
• Rate of PPI among valve types [Срок оценки: At 1-year follow-up]
• Pace dependency and pacing rate [Срок оценки: At 30-day follow-up]
• Pace dependency and pacing rate [Срок оценки: At 1-year follow-up]
• Factors associated with sudden death or permanent pacemaker implantation [Срок оценки: At 30-day follow-up]

Критерии участия

Критерии включения

-Patients with aortic valve disease undergoing transcatheter aortic valve replacement

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• IUCPQ — Québec

Публикации

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• 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, Cuiss PMID 28662806
• 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. PMID 28893961
• 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. PMID 29420704
• 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 F PMID 27883975
• 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. PMID 31439219
• 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 Ca PMID 30412710

Идентификаторы

NCT: NCT04139616 · PROMOTE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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