Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

NCT03561805 | Active Not Recruiting

• 1 other identifier: PARE
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arrythmia; Aortic Valve Stenosis

Keywords

TAVI; ECG monitoring

Outcome Measures

Primary Outcomes (2)

• Arrhythmic events

  Incidence and type of arrhythmic events

  Within 3 months prior to the TAVI procedure

• Therapeutic changes

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

  Within 3 months prior to the TAVI procedure

Secondary Outcomes (7)

• Atrial fibrillation

  Within 3 months prior to the TAVI procedure

• Atrial fibrillation

  Within 3 months prior to the TAVI procedure

• Atrioventricular block

  Within 3 months prior to the TAVI procedure

• Severe bradycardia

  Within 3 months prior to the TAVI procedure

• Left bundle branch block

  Within 3 months prior to the TAVI procedure

Study Arms (1)

Prolonged continuous ECG monitoring

OTHER

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.

Device: ECG monitoring

Interventions

ECG monitoring DEVICE

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

Prolonged continuous ECG monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Arrhythmias, Cardiac

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: June 19, 2018
• Study Start: June 1, 2017
• Primary Completion: January 31, 2020
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)