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Completed

NCT Number: NCT02326519

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

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.

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Key information

Conditions

Cardiac Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allgemeines Krankenhaus der Stadt Linz, Linz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • • Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)
  • 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

Treatment and study plan

Intracardiac electrode catheter

Other

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

Primary outcomes

  1. The electrical signal mean amplitude (mv) during AV synchronous pacing.

    Time frame: 2 minutes during the procedure

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: E20PC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 29, 2014
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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