Brief 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.
Brief Title
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
Detailed 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.
* 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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
418-656-8711
Central Contact Email
josep.rodes@criucpq.ulaval.ca
Central Contact Role
Contact
Central Contact Phone
418-656-8711
Central Contact Phone Ext
2646
Central Contact Email
melanie.cote@criucpq.ulaval.ca
Completion Date
Completion Date Type
Estimated
Conditions
Conduction Disturbances
Transcatheter Aortic Valve Replacement
Permanent Pacemaker Implantation
Eligibility Criteria
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
-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
Inclusion Criteria
Inclusion Criteria:
-Patients with aortic valve disease undergoing transcatheter aortic valve replacement
-Patients with aortic valve disease undergoing transcatheter aortic valve replacement
Gender
All
Gender Based
false
Keywords
atrioventricular block
complete heart block
high-degree atrioventricular block
intraventricular conduction delay
left bundle branch block
Permanent pacemaker implantation
Right bundle branch block
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04139616
Org Class
Other
Org Full Name
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Org Study Id
PROMOTE
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
Primary Outcomes
Outcome Measure
Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm
Outcome Time Frame
1 year follow-up
Outcome Measure
Incidence of permanent pacemaker implantation
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Incidence of permanent pacemaker implantation
Outcome Time Frame
At 1-year follow-up
Outcome Measure
Incidence of sudden death
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Incidence of sudden death
Outcome Time Frame
At 1-year follow-up
Secondary Outcomes
Outcome Description
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Outcome Time Frame
Before hospital discharge (between 1 to 30 days)
Outcome Measure
Rate, timing of and reasons for permanent pacemaker implantation
Outcome Description
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Rate, timing of and reasons for permanent pacemaker implantation
Outcome Description
Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm
Outcome Time Frame
At 1 year follow-up
Outcome Measure
Rate, timing of and reasons for permanent pacemaker implantation
Outcome Description
Rate and timing of sudden death in each group of the pre-specified algorithm
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Rate and timing of sudden death
Outcome Description
Rate and timing of sudden death in each group of the pre-specified algorithm
Outcome Time Frame
At 1-year follow-up
Outcome Measure
Rate and timing of sudden death
Outcome Description
Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge
Outcome Time Frame
After hospital discharge (up to 1-year)
Outcome Measure
Evaluation of arrhythmic events in patients with continuous ECG monitoring
Outcome Time Frame
After hospital discharge (up to 1-year)
Outcome Measure
Evaluation of the rate and timing of permanent pacemaker implantation
Outcome Description
Compare rate of permanent pacemaker implantation among different valve types
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Rate of PPI among valve types
Outcome Description
Compare rate of permanent pacemaker implantation among different valve types
Outcome Time Frame
At 1-year follow-up
Outcome Measure
Rate of PPI among valve types
Outcome Description
Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Pace dependency and pacing rate
Outcome Description
Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)
Outcome Time Frame
At 1-year follow-up
Outcome Measure
Pace dependency and pacing rate
Outcome Description
Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group
Outcome Time Frame
At 30-day follow-up
Outcome Measure
Factors associated with sudden death or permanent pacemaker implantation
Outcome Description
Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group
Outcome Time Frame
At 1-year follow-up
Outcome Measure
Factors associated with sudden death or permanent pacemaker implantation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients with aortic valve disease undergoing transcatheter aortic valve replacement without prior permanent pacemaker
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172