Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

NCT ID: NCT02057588

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arrythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LV Paced sites

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

Group Type OTHER

LV pacing site

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Suspicion of lead dislodgment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Sacher, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU haut leveque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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CR-12-082-FR-HV

Identifier Type: -

Identifier Source: org_study_id

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