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

Study acronym: PROMOTE
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion pushed from Dec 25, 2024 to Dec 25, 2025
    • Study completion pushed from Dec 25, 2026 to Dec 25, 2027
    v8
  2. Study completion date: Feb 25, 2025 to Dec 25, 2026v7
  3. Primary completion date: Feb 25, 2024 to Dec 25, 2024
    • Study title shortened, about 3 words
    v6
  4. Primary completion date: Feb 25, 2023 to Feb 25, 2024
    • Study completion date: Feb 25, 2024 to Feb 25, 2025
    v5
  5. Primary completion date: Feb 25, 2022 to Feb 25, 2023
    • Study completion date: Feb 25, 2023 to Feb 25, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Dec 2, 2019 to Feb 25, 2020
    • Study sites: 0 to 1
    • Primary completion date: Dec 2, 2022 to Feb 25, 2022
    • Study completion date: Dec 2, 2023 to Feb 25, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04139616
Lead Sponsor Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions
(from sponsor)		 Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
Related terms Atrioventricular Block, Bundle-Branch Block
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov