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

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Other: Standard follow-up; Other: CareLink Express RM system

Study type: Interventional

Funder types: Other

Identifiers

NCT04306978

0546-2015-0017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

CareLink Express RM system

Active Comparator group

Description:

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.

Treatment:

Other: CareLink Express RM system

Standard follow-up

Active Comparator group

Description:

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

Treatment:

Other: Standard follow-up