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NCT Number: NCT04139616

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

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.

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Key information

Conditions

Conduction Disturbances Arrhythmias, Cardiac Atrioventricular Block Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Permanent Pacemaker Implantation Transcatheter Aortic Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of successful algorithm implementation and percentage of patients in each arm of the pre-specified algorithm

    Time frame: 1 year follow-up

  2. Incidence of permanent pacemaker implantation

    Time frame: At 30-day follow-up

  3. Incidence of permanent pacemaker implantation

    Time frame: At 1-year follow-up

  4. Incidence of sudden death

    Time frame: At 30-day follow-up

  5. Incidence of sudden death

    Time frame: At 1-year follow-up

Secondary outcomes

  1. Rate, timing of and reasons for permanent pacemaker implantation

    Time frame: Before hospital discharge (between 1 to 30 days)

    Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm

  2. Rate, timing of and reasons for permanent pacemaker implantation

    Time frame: At 30-day follow-up

    Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm

  3. Rate, timing of and reasons for permanent pacemaker implantation

    Time frame: At 1 year follow-up

    Rate, timing of and reasons for permanent pacemaker implantation in each group of the pre-specified algorithm

  4. Rate and timing of sudden death

    Time frame: At 30-day follow-up

    Rate and timing of sudden death in each group of the pre-specified algorithm

  5. Rate and timing of sudden death

    Time frame: At 1-year follow-up

    Rate and timing of sudden death in each group of the pre-specified algorithm

  6. Evaluation of arrhythmic events in patients with continuous ECG monitoring

    Time frame: After hospital discharge (up to 1-year)

    Evaluation of arrhythmic events in patients with continuous ECG monitoring at hospital discharge

  7. Evaluation of the rate and timing of permanent pacemaker implantation

    Time frame: After hospital discharge (up to 1-year)

  8. Rate of PPI among valve types

    Time frame: At 30-day follow-up

    Compare rate of permanent pacemaker implantation among different valve types

  9. Rate of PPI among valve types

    Time frame: At 1-year follow-up

    Compare rate of permanent pacemaker implantation among different valve types

  10. Pace dependency and pacing rate

    Time frame: At 30-day follow-up

    Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)

  11. Pace dependency and pacing rate

    Time frame: At 1-year follow-up

    Determine the pace dependency and pacing rate in patients with periprocedural permanent pacemaker implantation (overall and in each subgroup of the algorithm)

  12. Factors associated with sudden death or permanent pacemaker implantation

    Time frame: At 30-day follow-up

    Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group

  13. Factors associated with sudden death or permanent pacemaker implantation

    Time frame: At 1-year follow-up

    Determine factors associated with sudden death or permanent pacemaker implantation during the follow-up period overall and in each algorithm group

Study contacts

Contact information is provided by the study sponsor or research team.

Josep Rodes-Cabau, MD

CONTACT

[email protected]

418-656-8711

Melanie Cote, MSc

CONTACT

[email protected]

418-656-8711 ext. 2646

Sponsors and collaborators

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Other

Registry information

Official study title

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

Acronym: PROMOTE

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Oct 25, 2019
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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