Validation of a management algorithm for heart conduction issues after TAVR
Official title: Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following Transcatheter Aortic Valve Replacement. The PROMOTE Study
Run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT04139616 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | February 25, 2020 |
| Main results expected | December 25, 2025 |
| Study ends | December 25, 2027 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT04139616 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with aortic valve disease who are scheduled to undergo transcatheter aortic valve replacement.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Iucpq
Québec, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Josep Rodes-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 418-656-8711
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI
This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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Low-dose Colchicine after TAVR to help prevent valve clots
This study tests whether taking a low dose of colchicine for 12 months after transcatheter aortic valve replacement can reduce valve thrombosis compared with standard care alone.
-
Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry
This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.
-
Using blood markers to predict conduction problems after TAVI
This study will test whether blood levels of inflammation and fibrosis markers taken before TAVI can help predict which patients with severe aortic stenosis will develop new conduction problems or need a permanent pacemaker.
-
Evaluation of the Point-Guard device during heart valve replacement
This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.