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NCT Number: NCT04298593

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

TAVI ECG Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiostat

Device

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.

Primary outcomes

  1. Incidence of arrhythmic events

    Time frame: within the first weeks after the procedure, an average of 4 weeks

    Incidence of arrhythmic events after discharge in TAVI recipients.

  2. Type of arrhythmic events

    Time frame: within the first weeks after the procedure, an average of 4 weeks

    Type of arrhythmic events after discharge in TAVI recipients.

  3. Incidence of arrhythmic events and treatment modification

    Time frame: within the first weeks after the procedure, an average of 4 weeks

    Incidence of arrhythmic events leading to a specific change in treatment.

  4. Type of arrhythmic events and treatment modification

    Time frame: within the first weeks after the procedure, an average of 4 weeks

    Type of arrhythmic events leading to a specific change in treatment.

Secondary outcomes

  1. Number of participants with pacemaker

    Time frame: Through study completion, an average of 5 years

    Incidence of permanent pacemaker implantation after the procedure.

  2. Number of participants with treatment modification

    Time frame: Through study completion, an average of 5 years

    Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Mar 6, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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