Validation of a management algorithm for heart conduction issues after TAVR
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
This study is testing a new plan to manage heart conduction problems that can happen after a TAVR procedure to see if it helps reduce the need for pacemakers and sudden deaths in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT04139616 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a pre-specified algorithm designed to manage conduction disturbances that occur following transcatheter aortic valve replacement (TAVR). It will assess the feasibility and efficacy of this algorithm by monitoring the rate of permanent pacemaker implantation and the incidence of sudden death in patients undergoing TAVR. By applying this standardized approach to a large cohort, the study seeks to improve clinical outcomes and reduce variability in treatment practices. The findings may provide insights into the best management strategies for patients experiencing these complications.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with aortic valve disease who are scheduled to undergo transcatheter aortic valve replacement.
Not a fit: Patients who have previously received a permanent pacemaker or are unable to follow the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with conduction disturbances post-TAVR, potentially reducing the need for permanent pacemaker implantation.
How similar studies have performed: While there is existing knowledge on conduction disturbances post-TAVR, this specific algorithmic approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec, Quebec
- Iucpq — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Josep Rodes-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.