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Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Primary Purpose

Aortic Valve Stenosis, Arrythmia

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

ECG monitoring

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring TAVI, ECG monitoring

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

IUCPQ

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prolonged continuous ECG monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Arrhythmic events

Incidence and type of arrhythmic events

Therapeutic changes

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

Secondary Outcome Measures

Atrial fibrillation

incidence of atrial fibrillation

Atrial fibrillation

duration of atrial fibrillation

Atrioventricular block

incidence of advanced atrioventricular block

Severe bradycardia

incidence of severe bradycardia

Left bundle branch block

incidence of left bundle branch block

Permanent pacemaker

percentage of patients with an indication of permanent pacemaker

Anticoagulation therapy

percentage of patients with an indication for anticoagulation therapy

Full Information

NCT ID

NCT03561805

First Posted

April 13, 2018

Last Updated

June 8, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT03561805

Brief Title

Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

January 31, 2020 (Actual)

Study Completion Date

June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis, Arrythmia

Keywords

TAVI, ECG monitoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prolonged continuous ECG monitoring

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

ECG monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Arrhythmic events

Description

Incidence and type of arrhythmic events

Time Frame

Within 3 months prior to the TAVI procedure

Title

Therapeutic changes

Description

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

Time Frame

Within 3 months prior to the TAVI procedure

Secondary Outcome Measure Information:

Title

Atrial fibrillation

Description

incidence of atrial fibrillation

Time Frame

Within 3 months prior to the TAVI procedure

Title

Atrial fibrillation

Description

duration of atrial fibrillation

Time Frame

Within 3 months prior to the TAVI procedure

Title

Atrioventricular block

Description

incidence of advanced atrioventricular block

Time Frame

Within 3 months prior to the TAVI procedure

Title

Severe bradycardia

Description

incidence of severe bradycardia

Time Frame

Within 3 months prior to the TAVI procedure

Title

Left bundle branch block

Description

incidence of left bundle branch block

Time Frame

Within 3 months prior to the TAVI procedure

Title

Permanent pacemaker

Description

percentage of patients with an indication of permanent pacemaker

Time Frame

Within 3 months prior to the TAVI procedure

Title

Anticoagulation therapy

Description

percentage of patients with an indication for anticoagulation therapy

Time Frame

Within 3 months prior to the TAVI procedure

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

IUCPQ

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

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Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

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