Transcatheter Aortic Valve Replacement Clinical Trial
— PROMOTEOfficial title:
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | February 25, 2025 |
Est. primary completion date | December 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 |
Country | Name | City | State |
---|---|---|---|
Canada | IUCPQ | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
Canada,
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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
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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 |
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