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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: CareLink Express RM system; Other: Standard follow-up

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergey E Mamchur, M.D., Ph.D.; Phone Number: +79132985516; Email: sergei_mamchur@mail.ru

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation, 650061
    • Recruiting
    • Research Institute for Complex Problems of Cardiovascular Diseases
    • Contact: Sergey E Mamchur, M.D., Ph.D.; Phone Number: +79132985516; Email: sergei_mamchur@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM	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)	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Anticipated): September 21, 2022
• Study Completion (Anticipated): January 21, 2023

Study Registration Dates

• First Submitted: December 23, 2018
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; remote monitoring; tromboembolism
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 0546-2015-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No