Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures (E20PC)

Medtronic

Status: Completed

Conditions: Cardiac Arrhythmias

Treatments: Other: Intracardiac electrode catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02326519

E20PC study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Intracardiac electrode catheter

Other group

Description:

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

Treatment:

Other: Intracardiac electrode catheter