Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Arrythmia Clinical Trial

Official title:

Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057588
• Other study ID #: CR-12-082-FR-HV
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: April 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Suspicion of lead dislodgment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia

Intervention

Procedure:
• LV 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

Locations

Country	Name	City	State
France	CHU haut leveque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method	Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.	Acute, intraoperative
Secondary	Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping	Use of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data	Acute, intraoperative