To establish evidence on the effectiveness of long term rhythm observation using an implantable loop recorder for detecting atrial fibrillation in patients with cryptogenic stroke.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients with documented AF based on implantable cardiac
monitor registration during a follow-up period of at least 12 months after an
episode of cryptogenic stroke. Compared to usual care consisting of an 12 lead
ECG upon outpatient clinic visit. An episode of AF is defined as an episode of
at least 120 seconds duration.
Secondary outcome
Secondary outcomes include time to first documented AF, incidence of recurrent
stroke or TIA and change of oral anticoagulation regimen. Progression of the
length and incidence of atrial fibrillation episodes.
Background summary
Recent studies demonstrated that prolonged rhythm observation increases the
detection of atrial fibrillation in patients prior diagnosed as cryptogenic
stroke. Detection of atrial fibrillation in these patients has important
therapeutic implications for the anticoagulation regimen. However, data on
optimal monitoring duration and method of AF detection are limited.
Study objective
To establish evidence on the effectiveness of long term rhythm observation
using an implantable loop recorder for detecting atrial fibrillation in
patients with cryptogenic stroke.
Study design
Extended rhythm observation for atrial fibrillation is a prospective single
center study with invasive measurements.
Study burden and risks
Using only a routine intervention will have minimal extra risk, burden for the
patients will be slightly increased due to the nature of an implantable loop
recorder. The device will be implanted under local anesthesia requiring a 2 cm
incision to place the device subcutaneously.
Haaksbergerstraat 55
Enschede 7513ER
NL
Haaksbergerstraat 55
Enschede 7513ER
NL
Listed location countries
Age
Inclusion criteria
Patients > 18 years of age
Recent episode (<=60 days) of cryptogenic ischemic stroke
Undetermined etiology with negative evaluation (including cardioembolism work-up) according to the TOAST criteria
Implantation of an implantable loop recorder within two months after index event
Able of providing informed consent
Exclusion criteria
Pre-existing indication for vitamin K antagonist
Untreated hyperthyroidism
Indication for pacemaker implantation, ICD or CRT device
Severe co-morbidity not likely to complete follow-up for one year
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36491.044.11 |