Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, tromboembolism, remote monitoring
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.
Interventions
OTHERCareLink 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
OTHERStandard 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)
Sponsors
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| hospitalization for cardiovascular events | 24 months | Number of participants with arrhythmia, heart failure decompensation, thromboembolic events |
| 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 |
| 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 |
| all-cause mortality | 24 months | Number of patients dead because of all causes |
| cardioversion | 24 months | Number of patinents underwent electrical cardioversion |
Countries
Russia
Contacts
Primary ContactSergey E Mamchur, M.D., Ph.D.
Outcome results
None listed