NCT02057588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

January 31, 2014

Last Update Submit

April 5, 2022

Conditions

Arrythmia

Keywords

ablation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Acute, intraoperative

Secondary Outcomes (1)

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

    Acute, intraoperative

Study Arms (1)

LV Paced sites

OTHER

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

Procedure: LV pacing site

Interventions

LV pacing sitePROCEDURE

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

LV Paced sites

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Suspicion of lead dislodgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU haut leveque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederic Sacher, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 7, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

FR(1)