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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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arrhythmic events
Therapeutic changes
Secondary outcome measures
Anticoagulation therapy
Atrial fibrillation
Atrioventricular block
+3 more

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

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
9,629 Total Patients Enrolled
4 Trials studying Aortic Valve Stenosis
659 Patients Enrolled for Aortic Valve Stenosis

Media Library

ECG monitoring (ECG Monitoring Device) Clinical Trial Eligibility Overview. Trial Name: NCT03561805 — N/A
Aortic Valve Stenosis Research Study Groups: Prolonged continuous ECG monitoring
Aortic Valve Stenosis Clinical Trial 2023: ECG monitoring Highlights & Side Effects. Trial Name: NCT03561805 — N/A
ECG monitoring (ECG Monitoring Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03561805 — N/A
~13 spots leftby Jun 2025
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