Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment2000 (estimated)
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval
Academic / other
Locations1 site (Québec, Quebec)
StatusRecruiting
StartedFebruary 25, 2020
Main results expectedDecember 25, 2025
Study endsDecember 25, 2027
Registry record updatedJune 1, 2026
Trial IDNCT04139616 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

  • Iucpq
    Québec, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 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.

    Recruiting Erasmus Medical Center · Düsseldorf and 4 other locations · NCT07872020

  • 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.

    Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

  • 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.

    Recruiting China National Center for Cardiovascular Diseases · Beijing · NCT07411768

  • 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.

    Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07370467

  • 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.

    Recruiting Clinical Hospital Center Rijeka · Rijeka, Croatia · NCT07201363

  • 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.

    Recruiting Transverse Medical, Inc. · Clayton, Victoria · NCT06962371

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.