Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation and Cardiovascular Risk Reduction in Patients With Implantable Cardiac Pacemakers
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM
Time Frame: 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 Outcomes
- the number of non-planned induced visits in the follow-up center(24 months)
- correction in the medical therapy(24 months)
- cardioversion(24 months)
- all-cause mortality(24 months)
- catheter/surgical PVI(24 months)
- thromboembolic events(24 months)
- hospitalization for cardiovascular events(24 months)
Investigators
Sergey Mamchur
Head of Department of Diagnosis of Cardiovascular Diseases
Research Institute for Complex Problems of Cardiovascular Diseases, Russia