Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT02057588

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arrythmia	Procedure: LV pacing site	N/A

Study Design

Study Type:

Interventional

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 :

Feb 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method [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

Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with SJM CRM device implanted for more than 90 days

Exclusion Criteria:

Suspicion of lead dislodgment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU haut leveque	Pessac		France	33604

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Frederic Sacher, MD, CHU Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT02057588

Other Study ID Numbers:

CR-12-082-FR-HV

First Posted:

Feb 7, 2014

Last Update Posted:

Apr 7, 2022

Last Verified:

Apr 1, 2022

Keywords provided by Abbott Medical Devices

ablation

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Apr 7, 2022