Back to resultsEnhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Primary Purpose
Arrythmia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LV pacing site
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrythmia focused on measuring ablation
Eligibility Criteria
Inclusion Criteria:
- Patient with SJM CRM device implanted for more than 90 days
Exclusion Criteria:
- Suspicion of lead dislodgment
Sites / Locations
- CHU haut leveque
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LV Paced sites
Arm Description
LV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02057588
Brief Title
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Official Title
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia
Keywords
ablation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LV Paced sites
Arm Type
Other
Arm Description
LV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization.
Intervention Type
Procedure
Intervention Name(s)
LV pacing site
Intervention Description
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 Measure Information:
Title
Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method
Description
Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method.
Time Frame
Acute, intraoperative
Secondary Outcome Measure Information:
Title
Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping
Description
Use of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data
Time Frame
Acute, intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with SJM CRM device implanted for more than 90 days
Exclusion Criteria:
Suspicion of lead dislodgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Sacher, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU haut leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
12. IPD Sharing Statement
Learn more about this trial
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms
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