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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04306978
• Other study ID #: 0546-2015-0017
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: January 21, 2023

Study information

• Verified date: March 2021
• Source: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
• Contact: Sergey E Mamchur, M.D., Ph.D.
• Phone: +79132985516
• Email: sergei_mamchur[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 21, 2023
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• 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)

Locations

Country	Name	City	State
Russian Federation	Research Institute for Complex Problems of Cardiovascular Diseases	Kemerovo

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

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