Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

Conditions
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TAVI, ECG Monitoring

Intervention / Treatment
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* Device: Cardiostat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ECG monitoring<br>All patient will be under telemetry | Device: Cardiostat<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of arrhythmic events | Incidence of arrhythmic events after discharge in TAVI recipients. | within the first weeks after the procedure, an average of 4 weeks | 
| Type of arrhythmic events | Type of arrhythmic events after discharge in TAVI recipients. | within the first weeks after the procedure, an average of 4 weeks | 
| Incidence of arrhythmic events and treatment modification | Incidence of arrhythmic events leading to a specific change in treatment. | within the first weeks after the procedure, an average of 4 weeks | 
| Type of arrhythmic events and treatment modification | Type of arrhythmic events leading to a specific change in treatment. | within the first weeks after the procedure, an average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with pacemaker | Incidence of permanent pacemaker implantation after the procedure. | Through study completion, an average of 5 years | 
| Number of participants with treatment modification | Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure. | Through study completion, an average of 5 years |