Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Arrythmia
• Intervention / Treatment: Device: ECG monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • IUCPQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Prolonged continuous ECG monitoring; 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; Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	incidence of atrial fibrillation	Within 3 months prior to the TAVI procedure
Atrial fibrillation	duration of atrial fibrillation	Within 3 months prior to the TAVI procedure
Atrioventricular block	incidence of advanced atrioventricular block	Within 3 months prior to the TAVI procedure
Severe bradycardia	incidence of severe bradycardia	Within 3 months prior to the TAVI procedure
Left bundle branch block	incidence of left bundle branch block	Within 3 months prior to the TAVI procedure
Permanent pacemaker	percentage of patients with an indication of permanent pacemaker	Within 3 months prior to the TAVI procedure
Anticoagulation therapy	percentage of patients with an indication for anticoagulation therapy	Within 3 months prior to the TAVI procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: TAVI; ECG monitoring
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Signs and Symptoms; Aortic Valve Stenosis; Arrhythmias, Cardiac; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: PARE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No