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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057588
Recruitment Status : Recruiting
First Posted : February 7, 2014
Last Update Posted : April 7, 2020
Sponsor:
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)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02057588


Contacts
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Contact: Cyrille Casset, Ing. +33 (0)6.87.86.08.07 ccasset@sjm.com

Locations
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France
CHU haut leveque Recruiting
Pessac, France, 33604
Contact: Piquet Maider, CRA    +33 (0)5.57.62.33.96    maider.piquet@chu-bordeaux.fr   
Principal Investigator: Frederic Sacher, Md         
Sub-Investigator: Pierre Jais, Phd         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Frederic Sacher, MD CHU Bordeaux
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02057588    
Other Study ID Numbers: CR-12-082-FR-HV
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Abbott Medical Devices:
ablation
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes