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Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02057588
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : April 7, 2022
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Arrythmia Procedure: LV pacing site Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
LV Paced sites
LV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization.
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

Primary Outcome Measures :
  1. Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method [ Time Frame: Acute, intraoperative ]
    Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.

Secondary Outcome Measures :
  1. Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping [ Time Frame: Acute, intraoperative ]
    Use of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Suspicion of lead dislodgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02057588

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CHU haut leveque
Pessac, France, 33604
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Frederic Sacher, MD CHU Bordeaux
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Responsible Party: Abbott Medical Devices Identifier: NCT02057588    
Other Study ID Numbers: CR-12-082-FR-HV
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022
Keywords provided by Abbott Medical Devices:
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes