Evaluation of the AF detection performance of the BioMonitor III ICM in patients who are scheduled for a PVI in comparison to simultaneous Holter monitoring.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are the sensitivity, specificity, positive predictive value
and negative predictive value of AF detection by the BioMonitor III in
comparison to Holter monitoring at the 2 timepoints (pre- and post PVI).
Secondary outcome
The secondary objective is to demonstrate the freedom from ICM- or
insertion-related complications at 6 months post-ICM insertion.
Background summary
Pulmonary vein isolation (PVI) is the cornerstone of interventional treatment
of symptomatic atrial fibrillation (AF). Several methods are available to
establish the efficacy of catheter ablation of AF. According to the 2017
HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical
ablation of AF, the minimal monitoring recommendations for paroxysmal or
persistent AF recurrence post-ablation does not include an ICM; however, in the
setting of clinical trials, extended ECG monitoring is encouraged. The
commercially available insertable cardiac monitors (ICMs) have different AF
detection algorithms, but are largely based on R-R interval irregularity. Runs
of ectopy with irregular coupling intervals, undersensing of beats, oversensing
of myopotentials, or underlying sinus arrhythmia may be sources of false
positive AF detection. The BioMonitor III is a new ICM with a long sensing
vector with gives a better R-wave amplitude. Currently, there is no data on the
AF-detection performance of the BioMonitor III ICM. The aim of the current
study is to provide data on the AF performance of the BioMonitor III ICM
specifically in patients who undergo PVI.
Study objective
Evaluation of the AF detection performance of the BioMonitor III ICM in
patients who are scheduled for a PVI in comparison to simultaneous Holter
monitoring.
Study design
Single-center prospective observational study in which the AF detection
performance of the BioMonitor III ICM will be investigated before and after
PVI.
Study burden and risks
Implantation of an ICM is a relatively simple procedure with a low risk of
periprocedural complications. The device is placed subcutaneously using local
anesthetics. The most important complications are pocket infection and local
hematoma, which are generally well manageable. The BioMonitor III is CE marked.
Holter monitoring is a standard non-invasive diagnostic tool used in the
outpatient clinic.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of paroxysmal or persistent AF as defined by the 2016 ESC
guidelines for the management of atrial fibrillation
2. Subject scheduled to undergo PVI within 6 months
3. Subject willing and able to comply with the follow-up requirements of the
study
4. Written informed consent obtained from subject aged 18 years or older
Exclusion criteria
1. Diagnosis of long-standing persistent AF as defined by the 2016 ESC
guidelines for the management of atrial fibrillation
2. Subjects implanted with a previous ICM, pacemaker, ICD, or cardiac
resynchronization therapy device
3. Subjects with an active infection
4. Subjects enrolled in another clinical study which may confound the results
of this study
5. Subjects with a life expectancy of <1 year due to any condition
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL70462.078.19 |
| Other | NL7777 |
| OMON | NL-OMON23516 |