Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atriovent… (NCT05714579) | Clinical Trial Compass
TerminatedNot Applicable
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
Stopped: The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study
France35 participantsStarted 2023-05-30
Plain-language summary
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
* Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
* Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
* Patient having signed a consent.
Exclusion Criteria:
* Contraindication to Transcatheter Aortic Valve Implantation ;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implantation of a Pacemaker at 30 days
Timeframe: 30 days
Trial details
NCT IDNCT05714579
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche