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Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02057588
Enrollment
16
Registered
2014-02-07
Start date
2014-02-28
Completion date
2016-06-30
Last updated
2022-04-07

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

Conditions

Arrythmia

Keywords

ablation

Brief summary

The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.

Interventions

PROCEDURELV pacing site

Patient will be paced in VVI mode from Left ventricle specific position for a short period of time per position in order to cover spontaneous ventricular activity

Sponsors

Abbott Medical Devices
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with SJM CRM device implanted for more than 90 days

Exclusion criteria

* Suspicion of lead dislodgment

Design outcomes

Primary

MeasureTime frameDescription
Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based methodAcute, intraoperativeCorrelation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.

Secondary

MeasureTime frameDescription
Ventricular activation origin location determined by IEGMs based method vs. by detailed mappingAcute, intraoperativeUse of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026