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Continuous Electrocardiogram Monitoring for TAVR Patients

N/A

Waitlist Available

Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 years

Awards & highlights

Study Summary

This trial suggests that ECG continuous monitoring could be useful for TAVI recipients to manage arrhythmic events.

Who is the study for?

This trial is for patients with severe aortic stenosis who are about to undergo TAVI using balloon or self-expandable valves. It's not for those who may die in the hospital, can't be monitored by ECG after the procedure, already have a pacemaker, won't consent to the study, or are in another similar ECG monitoring trial.Check my eligibility

What is being tested?

The RECORD Study is testing continuous ECG monitoring using Cardiostat on patients after they've had TAVI. The goal is to see if this monitoring helps catch and treat heart rhythm problems that happen right after the surgery.See study design

What are the potential side effects?

Since this trial involves non-invasive ECG monitoring rather than medication or invasive procedures, side effects are minimal but could include skin irritation from electrode placement and potential anxiety from continuous health tracking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe aortic stenosis and am undergoing TAVI with a specific type of valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of arrhythmic events

Incidence of arrhythmic events and treatment modification

Type of arrhythmic events

+1 more

Secondary outcome measures

Number of participants with pacemaker

Number of participants with treatment modification

Trial Design

1Treatment groups

Experimental Treatment

Group I: ECG monitoringExperimental Treatment1 Intervention

All patient will be under telemetry

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor

36 Previous Clinical Trials

9,542 Total Patients Enrolled

1 Trials studying Transcatheter Aortic Valve Replacement (TAVR)

2,000 Patients Enrolled for Transcatheter Aortic Valve Replacement (TAVR)

Institut universitaire de cardiologie et de pneumologie de Québec, University LavalLead Sponsor

18 Previous Clinical Trials

3,283 Total Patients Enrolled

1 Trials studying Transcatheter Aortic Valve Replacement (TAVR)

20 Patients Enrolled for Transcatheter Aortic Valve Replacement (TAVR)

Media Library

ECG monitoring Clinical Trial Eligibility Overview. Trial Name: NCT04298593 — N/A

Transcatheter Aortic Valve Replacement (TAVR) Research Study Groups: ECG monitoring

Transcatheter Aortic Valve Replacement (TAVR) Clinical Trial 2023: ECG monitoring Highlights & Side Effects. Trial Name: NCT04298593 — N/A

ECG monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298593 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available to enroll in the trial?

"The clinicaltrial.gov database states that this trial is not taking on any new participants at present, despite the last update being July 7th 2022. Nevertheless, there are 12 other trials actively recruiting patients currently."

Answered by AI

Recent research and studies

BMC Cardiovascular DisordersJournal

Aortic Stenosis and Mitral Regurgitation as Predictors of Atrial Fibrillation During 11 Years of Follow-up

Widgren, Veronica, Magnus Dencker, Tord Juhlin, Pyotr Platonov, and Ronnie Willenheimer. 2012. “Aortic Stenosis and Mitral Regurgitation as Predictors of Atrial Fibrillation During 11 Years of Follow-up”. BMC Cardiovascular Disorders. Springer Science and Business Media LLC. doi:10.1186/1471-2261-12-92.

Revista Española de Cardiología (English Edition)Journal

2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease

Baumgartner, Helmut, Volkmar Falk, Jeroen J. Bax, Michele De Bonis, Christian Hamm, Per Johan Holm, Bernard Iung, et al.. 2018. “2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease”. Revista Española De Cardiología (english Edition). Elsevier BV. doi:10.1016/j.rec.2017.12.013.

CirculationJournal

Cause of Complete Atrioventricular Block After Percutaneous Aortic Valve Implantation

Moreno, Raul, David Dobarro, Esteban López de Sá, Mario Prieto, Carmen Morales, Luis Calvo Orbe, Isidro Moreno-Gomez, et al.. 2009. “Cause of Complete Atrioventricular Block After Percutaneous Aortic Valve Implantation”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.109.849281.

HeartJournal