Active — Not RecruitingNot Applicable

Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

Canada200 participantsStarted 2019-06-28

Plain-language summary

TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.

Who can participate

Age range

18 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: * Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves. Exclusion Criteria: * Failure to provide informed consent. * Prior or post-procedural pacemaker * In-hospital death * Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure * Participation in another continuous ECG monitoring post-TAVI trial

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

Incidence of arrhythmic events

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Incidence of arrhythmic events and treatment modification

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events and treatment modification

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Trial details

NCT IDNCT04298593

SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More TAVI trials

Who can participate

Age range

18 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.

What they're measuring

Incidence of arrhythmic events

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Incidence of arrhythmic events and treatment modification

Timeframe: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events and treatment modification

Timeframe: within the first weeks after the procedure, an average of 4 weeks