NCT04306978

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

Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation and Cardiovascular Risk Reduction in Patients With Implantable Cardiac Pacemakers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	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
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)

Timeline

• Start date: 2017-09-21
• Primary completion: 2022-09-21
• Completion: 2023-01-21
• First posted: 2020-03-13
• Last updated: 2021-03-10

Locations

1 site across 1 country: Russia