Aortic Valve Stenosis, Arrythmia
Conditions
Keywords
TAVI, ECG monitoring
Brief summary
Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.
Detailed description
This is a prospective registry including patients accepted by the heart team for a TAVI procedure. 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. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.
Interventions
DEVICEECG monitoring
Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.
Exclusion criteria
* Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure. * Prior permanent pacemaker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmic events | Within 3 months prior to the TAVI procedure | Incidence and type of arrhythmic events |
| Therapeutic changes | Within 3 months prior to the TAVI procedure | incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation | Within 3 months prior to the TAVI procedure | incidence of atrial fibrillation |
| Atrioventricular block | Within 3 months prior to the TAVI procedure | incidence of advanced atrioventricular block |
| Severe bradycardia | Within 3 months prior to the TAVI procedure | incidence of severe bradycardia |
| Left bundle branch block | Within 3 months prior to the TAVI procedure | incidence of left bundle branch block |
| Permanent pacemaker | Within 3 months prior to the TAVI procedure | percentage of patients with an indication of permanent pacemaker |
| Anticoagulation therapy | Within 3 months prior to the TAVI procedure | percentage of patients with an indication for anticoagulation therapy |
Countries
Canada
Outcome results
None listed