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ECG Monitoring Device

ECG Monitoring for Aortic Stenosis

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 accepted for a TAVI procedure by the Heart Team.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months prior to the tavi procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether arrhythmias are more common in people with aortic stenosis who are candidates for TAVI. If so, then detecting and treating these arrhythmias before the TAVI procedure may improve patient outcomes.

Who is the study for?

This trial is for patients with severe aortic stenosis who are scheduled for a TAVI (Transcatheter Aortic Valve Implantation) procedure. Candidates must not require an urgent TAVI and should be able to undergo ECG monitoring for at least one week within three months before the procedure. Those with prior permanent pacemakers are excluded.

What is being tested?

The study is testing whether prolonged continuous ECG monitoring before a TAVI procedure can detect silent arrhythmic events, which could lead to better pre-procedural treatment plans, improved patient outcomes, and reduced hospital stays after the surgery.

What are the potential side effects?

ECG monitoring is generally safe but may cause minor discomfort where electrodes attach to the skin. There's also a small risk of skin irritation or allergic reaction to adhesive pads used during the monitoring period.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been approved for a TAVI procedure due to severe aortic stenosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 months prior to the tavi procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 months prior to the tavi procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months prior to the tavi procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Arrhythmic events

Therapeutic changes

Secondary study objectives

Anticoagulation therapy

Atrial fibrillation

Atrioventricular block

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prolonged continuous ECG monitoringExperimental Treatment1 Intervention

Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ECG monitoring

2020

N/A

~60

0 / 1Eligibility criteria met