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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Other: CareLink Express RM system; Other: Standard follow-up

• Registration Number: NCT04306978
• Lead Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Brief 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.

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2018-12-23
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2022-09-21
• Study Completion: 2023-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CareLink Express RM system	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.
Standard follow-up	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

Primary Outcome Measures

Name	Time	Method
time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM	24 months	the episode should be evaluated by the follow-up clinic physician(s) and meet the appropriate criteria (irregular RR intervals and distinct P waves, ≥30s episode duration)

Secondary Outcome Measures

Name	Time	Method
the number of non-planned induced visits in the follow-up center	24 months	Number of visits for 1 patient per year
correction in the medical therapy	24 months	Number of participants with antiarrhythmic therapy or/and oral anticoagulation therapy initiated after the AF detection
cardioversion	24 months	Number of patinents underwent electrical cardioversion
all-cause mortality	24 months	Number of patients dead because of all causes
hospitalization for cardiovascular events	24 months	Number of participants with arrhythmia, heart failure decompensation, thromboembolic events
thromboembolic events	24 months	Number of participants with ischaemic stroke, transient ischaemic attack and thromboembolism (including any arterial embolism and paradoxical embolism)
catheter/surgical PVI	24 months	Number of patients underwent catheter or surgical atrial fibrillation ablation

Trial Locations

Locations (1)

Research Institute for Complex Problems of Cardiovascular Diseases; 🇷🇺 Kemerovo, Russian Federation