The purpose of this clinical investigation is to assess the accuracy of the Confirm DM2102 ICM in the detection of episodes of Atrial Fibrillation (AF).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess SJM Confirm ICM performance through the sensitivity and positive
predictive values of AF episodes of at least 2 minutes in length,
utilizing the data collected during the Holter recording.
Secondary outcome
- To assess SJM Confirm ICM performance through the specificity and negative
predictive values, utilizing the data collected during the Holter
recording.
- To assess AF detection of episodes at least 6 minutes in length
Background summary
Atrial Fibrillation (AF) is the most commonly diagnosed arrhythmia. ECG
monitoring is recommended for diagnosis of AF.Tools for monitoring include
Holter monitoring patient- and automatically activated devices, external loop
recorders and implantable cardiac monitors. External monitoring is subject to
patient compliance which can be limiting depending on the duration of the
monitoring and the follow-up scheme used.
Implantable Cardiac Monitors (ICM) have been used as a way to continuously
monitor cardiac rhythm especially in case of unexplained syncope. Patients with
clinical syndromes or situations at increased risk of cardiac arrhythmias or
patients who experience transient symptoms that may suggest a cardiac
arrhythmia can benefit from the minimally invasive implantable subcutaneous
monitoring device.
SJM Confirm ICM, DM2102, is a new ICM that includes an AF detection feature and
diagnostics.
This study aims to assess the performance of this device in a clinical setting.
Study objective
The purpose of this clinical investigation is to assess the accuracy of the
Confirm DM2102 ICM in the detection of episodes of Atrial Fibrillation (AF).
Study design
This is an international, multi-center, prospective, non-randomized,
observational investigation.
Study burden and risks
The subject is not exposed to additional risk, but might be hindered by
carrying the holter recorder during the 4 day holter period.
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Standaardruiter 13
VEENENDAAL 3905 PT
NL
Listed location countries
Age
Inclusion criteria
- The subject has been implanted with a SJM Confirm ICM, DM2102.
- The subject has or is suspected to have paroxysmal AF.
- The subject is * 18 years of age.
- The subject is willing and able to provide written Informed Consent (prior to any
investigational related procedure).
Exclusion criteria
- The subject has persistent (>7 days and <1 year or AF requiring cardioversion),
longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to
restore sinus rhythm).
- The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
- The subject has a contraindication to Holter recording.
- The subject has already received an active implantable medical device other than the
SJM Confirm ICM, DM2102.
- The subject is unable to comply with the follow up schedule.
- The subject is participating in another investigational device or drug investigation.
- The subject is pregnant or is planning to become pregnant during the duration of the
investigation.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL41093.098.12 |