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

Study Overview
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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.

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

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Other: Intracardiac electrode catheter


Participation Criteria
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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: • 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intracardiac electrode catheter<br>All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter. | Other: Intracardiac electrode catheter<br>* All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The electrical signal mean amplitude (mv) during AV synchronous pacing. |  | 2 minutes during the procedure |