ECG Monitoring, TAVI
Conditions
Brief summary
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.
Detailed description
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 after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any 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 diagnosis of the arrhythmic event. Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.
Interventions
DEVICECardiostat
This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.
Sponsors
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.
Exclusion criteria
* Failure to provide informed consent. * Prior or post-procedural pacemaker * In-hospital death * Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure * Participation in another continuous ECG monitoring post-TAVI trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of arrhythmic events | within the first weeks after the procedure, an average of 4 weeks | Incidence of arrhythmic events after discharge in TAVI recipients. |
| Type of arrhythmic events | within the first weeks after the procedure, an average of 4 weeks | Type of arrhythmic events after discharge in TAVI recipients. |
| Incidence of arrhythmic events and treatment modification | within the first weeks after the procedure, an average of 4 weeks | Incidence of arrhythmic events leading to a specific change in treatment. |
| Type of arrhythmic events and treatment modification | within the first weeks after the procedure, an average of 4 weeks | Type of arrhythmic events leading to a specific change in treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with pacemaker | Through study completion, an average of 5 years | Incidence of permanent pacemaker implantation after the procedure. |
| Number of participants with treatment modification | Through study completion, an average of 5 years | Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure. |
Countries
Canada
Outcome results
None listed