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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cardiostat: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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