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Active, Not Recruiting

NCT Number: NCT03561805

Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Arrhythmias, Cardiac Arrythmia Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

About this study

This is a 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 within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no 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 occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 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 accepted for a TAVI procedure by the Heart Team.

Exclusion criteria

  • Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
  • Prior permanent pacemaker.

Treatment and study plan

ECG monitoring

Device

Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure

Primary outcomes

  1. Arrhythmic events

    Time frame: Within 3 months prior to the TAVI procedure

    Incidence and type of arrhythmic events

  2. Therapeutic changes

    Time frame: Within 3 months prior to the TAVI procedure

    incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure

Secondary outcomes

  1. Atrial fibrillation

    Time frame: Within 3 months prior to the TAVI procedure

    incidence of atrial fibrillation

  2. Atrial fibrillation

    Time frame: Within 3 months prior to the TAVI procedure

    duration of atrial fibrillation

  3. Atrioventricular block

    Time frame: Within 3 months prior to the TAVI procedure

    incidence of advanced atrioventricular block

  4. Severe bradycardia

    Time frame: Within 3 months prior to the TAVI procedure

    incidence of severe bradycardia

  5. Left bundle branch block

    Time frame: Within 3 months prior to the TAVI procedure

    incidence of left bundle branch block

  6. Permanent pacemaker

    Time frame: Within 3 months prior to the TAVI procedure

    percentage of patients with an indication of permanent pacemaker

  7. Anticoagulation therapy

    Time frame: Within 3 months prior to the TAVI procedure

    percentage of patients with an indication for anticoagulation therapy

Sponsors and collaborators

Lead sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Other

Registry information

Official study title

Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
Jun 19, 2018
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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