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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged continuous ECG monitoring | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG monitoring | Device | Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Arrhythmic events | Incidence and type of arrhythmic events | Within 3 months prior to the TAVI procedure |
| Therapeutic changes | incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure | Within 3 months prior to the TAVI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation | incidence of atrial fibrillation | Within 3 months prior to the TAVI procedure |
| Atrial fibrillation | duration of atrial fibrillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IUCPQ | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| Within 3 months prior to the TAVI procedure |
| Atrioventricular block | incidence of advanced atrioventricular block | Within 3 months prior to the TAVI procedure |
| Severe bradycardia | incidence of severe bradycardia | Within 3 months prior to the TAVI procedure |
| Left bundle branch block | incidence of left bundle branch block | Within 3 months prior to the TAVI procedure |
| Permanent pacemaker | percentage of patients with an indication of permanent pacemaker | Within 3 months prior to the TAVI procedure |
| Anticoagulation therapy | percentage of patients with an indication for anticoagulation therapy | Within 3 months prior to the TAVI procedure |
| D014694 |
| Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |