Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2023-01-21

Brief Summary

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The study results will be used to check the hypothesis that CareLink Express remote monitoring system increases the detection rate of asymptomatic AF and allows to change timely the treatment strategy in patients at high risk of thromboembolic events, e.g. anticoagulation therapy onset, electrical cardioversion or/and PVI.

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Detailed Description

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It is expected to enroll 200 consecutive patients without previously diagnosed AF, who have indications for implantation of dual chamber cardiac pacemakers according to the current guidelines. All the patients will be randomly assigned into 2 groups. Patients in the RM group will undergo the implantation of Ensura DR MRI SureScan pacing system, whereas patients in the control group will receive ADAPTA DR pacing system without RM using. The impact of the Care Link Express service on prevention of thromboembolism will be evaluated. The rate of in-hospital visits for 1 patient per year and compliance with scheduled CareLink transmissions (ratio of the number of the performed transmissions to the planned ones) will be assessed in all patients in the remote monitoring group. Moreover, we are going to estimate the interaction between the follow-up center and other healthcare facilities equipped with the CareLink Express service, which will facilitate faster treatment decision.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CareLink Express RM system

Patients in the remote monitoring (RM) group will undergo the implantation of Ensura DR MRI SureScan pacing system. Patients in the RM group should visit the main follow-up clinic 12 weeks after discharge, and then the device data will be remotely transmitted to the CareLink Express Network at least once in 3 months. Research personnel will contact patients by telephone once in 6 months. If participants indicate they have experienced a study outcome event (corresponding to the study endpoints), the event will be recorded. If remote transmission or telephone call data require to make clinical decision an in-hospital visit will be induced.

Group Type ACTIVE_COMPARATOR

CareLink Express RM system

Intervention Type OTHER

CareLink Express remote monitoring system consists of implantable pacemaker CareLink Express station for implanted Medtronic cardiac devices and provides remote data transmissions

Standard follow-up

Patients in the control group will receive Adapta DR pacing system without remote monitoring using. All patients from the control group should have the first in-hospital visit 12 weeks after pacemaker implantation. Then, the follow-up will be provided according to the standard guidelines

Group Type ACTIVE_COMPARATOR

Standard follow-up

Intervention Type OTHER

Follow-up will be provided according to the standard guidelines (HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations; 2008)

Interventions

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CareLink Express RM system

CareLink Express remote monitoring system consists of implantable pacemaker CareLink Express station for implanted Medtronic cardiac devices and provides remote data transmissions

Intervention Type OTHER

Standard follow-up

Follow-up will be provided according to the standard guidelines (HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations; 2008)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients with indications for implantation of dual chamber cardiac pacemaker
* patients with no AF history;
* written informed consent.

Exclusion Criteria

* patients with contraindications for CIED implantation;
* patients with previously implanted CIEDs;
* infection;
* patients with previously diagnosed AF

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No