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

NCT04298593 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • TAVI
  • ECG Monitoring

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2021-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298593 on ClinicalTrials.gov