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Surface vs Subcutaneous ECG study

Surface vs Subcutaneous ECG study - SUSE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30295
Enrollment
45
Registered
2007-02-09
Start date
2006-12-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ECG diagnostiek not applicable - ECG diagnostics

Interventions

None listed

Sponsors

Vitatron
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Minimum age of 18 years - Reveal® Plus ILR implantation at least 6 weeks ago

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)