The primary objective involves comparison of the sensing performance of surface and subcutaneous ECGs at rest, and comparison of sensing performance of surface and subcutaneous ECGs during exercise.
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
ECG diagnostiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity of the R-wave detection and the Positive Predictive Value are
the indicators for the quality and sensing performance of different ECG
signals.
Secondary outcome
Signal to noise ratio as well as morphology metrics will be analyzed to asses
signal characteristics of the various ECG signals and compare the different
signal characteristics. The parameters for the morphology analysis are not
fully defined at this time. These will include but are not limited to QRS
complex morphology, amplitudes of the different components of the QRS complex,
P-waves and T-waves and will be further defined during the analysis.
Background summary
This study will be conducted in order to investigate the difference between the
subcutaneous ECG signals recorded by the Reveal® Plus Insertable Loop Recorder
(ILR) system and surface ECG signals recorded by a DR180+ Digital Holter
Recorder (external Holter). Insight will be obtained on the influence of motion
artifacts on surface ECG and subcutaneous ECG signal recordings.
The outcome of this study is expected to support the use of surface ECG signals
to test ILR detection algorithms. Furthermore, demonstration that surface ECG
signal recordings (obtained via an external Holter) are a good surrogate for
subcutaneous ECG signal recording by the ILR, will support the pre-implant
mapping procedure, which is used to find the most optimal orientation of the
ILR to ensure optimal sensing.
Study objective
The primary objective involves comparison of the sensing performance of surface
and subcutaneous ECGs at rest, and comparison of sensing performance of surface
and subcutaneous ECGs during exercise.
Study design
The SUSE study is a prospective, non-randomized, multi-center, post-market
study.
The study consists of one visit only during which patients with a Reveal® Plus
ILR will be connected with a DR180+ Digital Holter. During an in-office
procedure the surface ECG signals will be recorded via the DR180+ Digital
Holter Recorder and the subcutaneous ECG signal will be recorded with the
Reveal® Plus ILR. This will be done while the patients are in different
positions (rest) and during specific movements (exercise).
Study burden and risks
The study-related procedures are expected to prolong subject*s standard Reveal®-
related visits (e.g. follow-ups) by 20 minutes and are considered to entail
minimal risk. The potential risks to a subject are believed to be the same as
those encountered during standard ECG testing or Holter recording. The risks
involved in this study include but are not limited to irritation or an allergic
reaction to the adhesive used to secure the surface electrodes to the skin.
There are no direct benefits for participating subjects.
P.O. Box 5227
6802 EE
Nederland
P.O. Box 5227
6802 EE
Nederland
Listed location countries
Age
Inclusion criteria
- Minimum age of 18 years
- Reveal® Plus ILR implantation at least 6 weeks ago
Exclusion criteria
- Patient is not able to perform physical maneuvers with the hands and arms,
- Patient is not able to walk,
- Patient is not able to stand,
- Patient is participating in a study that is expected to compromise the results of this study,
- Patient has an allergy against the adhesive Lead-Lok electrodes.
Design
Recruitment
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 | NL15147.094.06 |