Continuous Electrocardiogram Monitoring for TAVR Patients

Overseen By Emilie Pelletier Beaumont, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Disqualifiers: Pacemaker, In-hospital death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cardiostat for TAVR patients?

The study on wearable smartwatches for TAVR patients shows that remote monitoring can effectively detect cardiac events, with 76% of events confirmed by the smartwatch, suggesting that continuous ECG monitoring, like Cardiostat, could be beneficial in identifying and managing heart issues early. ^{1 2 3 4 5}

Is continuous ECG monitoring safe for TAVR patients?

A study using smartwatches for continuous ECG monitoring in TAVR patients showed that most cardiac events were detected safely, and some patients required further treatment like pacemaker implantation. The monitoring was generally safe and helped in remote health care management. ^{1 2 6 7 8}

How does continuous electrocardiogram monitoring differ from other treatments for TAVR patients?

Continuous electrocardiogram monitoring for TAVR patients is unique because it allows for the detection of unknown arrhythmic events (irregular heartbeats) before the procedure, which can lead to changes in treatment plans. This approach is different from traditional methods that may not identify these issues until after the procedure. ^{1 2 9 10 11}

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

You have a pacemaker implanted before or after a medical procedure.

Failure to provide informed consent.

Not applicable as I am alive.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TAVI Procedure

Participants undergo the Transcatheter Aortic Valve Implantation (TAVI) procedure

1 day

Post-Procedural Monitoring

Continuous ECG monitoring using the CardioSTAT® device after hospital discharge

4 weeks

2 visits (in-person) at 2 and 4 weeks

Follow-up

Participants are monitored for arrhythmic events and treatment modifications

5 years

Yearly visits up to 5 years

Treatment Details

Interventions

• Cardiostat

Trial Overview 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.

Participant Groups

Group I: ECG monitoring Experimental Treatment 1 Intervention

All patient will be under telemetry

Who Is Running the Clinical Trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Lead Sponsor

Trials

37

Recruited

9,700+

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

Lead Sponsor

Trials

26

Recruited

6,300+

References

1. England pubmed.ncbi.nlm.nih.gov

Wearable Smartwatch Facilitated Remote Health Management for Patients Undergoing Transcatheter Aortic Valve Replacement. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes of transcatheter aortic valve replacement stratified by left ventricular ejection fraction: A single centre pilot study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Electrocardiographic and electrophysiological predictors of atrioventricular block after transcatheter aortic valve replacement. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

The Electrocardiogram After Transcatheter Aortic Valve Replacement Determines the Risk for Post-Procedural High-Degree AV Block and the Need for Telemetry Monitoring. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Patients Undergoing Transcatheter Aortic Valve Replacement: A Framework for Postprocedural Telemonitoring. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria. [2023]

7. England pubmed.ncbi.nlm.nih.gov

New-onset arrhythmias following transcatheter aortic valve implantation: a systematic review and meta-analysis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Incidence, Predictors, and Prognostic Impact of Bleeding Events After TAVR According to VARC-3 Criteria. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Prolonged Continuous Electrocardiographic Monitoring Prior to Transcatheter Aortic Valve Replacement: The PARE Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Delayed Total Atrioventricular Block After Transcatheter Aortic Valve Replacement Assessed by Implantable Loop Recorders. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Non-continuous mobile electrocardiogram monitoring for post-transcatheter aortic valve replacement delayed conduction disorders put to the test. [2023]