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Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

NCT ID: NCT02326519

Last Updated: 2017-12-20

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2015-03-13

Brief Summary

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Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Detailed Description

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The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.

Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Conditions

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Cardiac Arrhythmias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intracardiac electrode catheter

All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter.

Group Type OTHER

Intracardiac electrode catheter

Intervention Type OTHER

All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter

Interventions

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Intracardiac electrode catheter

All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted

* Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed
* Subjects are willing to provide Informed Consent

Exclusion Criteria

* Any condition which precludes the subject's ability to comply with the study requirements
* Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allgemeines Krankenhaus der Stadt Linz

Linz, , Austria

Site Status

Hôpital Cardiologique du Haut-Lévêque

Bordeaux, , France

Site Status

Countries

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Austria France

Other Identifiers

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E20PC study

Identifier Type: -

Identifier Source: org_study_id