Clinical trial NCT04306978: Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
tromboembolism
remote monitoring
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM
timeFrame: 24 months
Secondary outcomes:
measure: thromboembolic events
timeFrame: 24 months
measure: hospitalization for cardiovascular events
timeFrame: 24 months
measure: the number of non-planned induced visits in the follow-up center
timeFrame: 24 months
measure: correction in the medical therapy
timeFrame: 24 months
measure: cardioversion
timeFrame: 24 months
measure: catheter/surgical PVI
timeFrame: 24 months
measure: all-cause mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Problems of Cardiovascular Diseases
Study officials:
References: