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

Not Applicable

Completed

• Conditions: Cardiac Arrhythmias
• Interventions: Other: Intracardiac electrode catheter

• Registration Number: NCT02326519
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Primary Completion: 2015-01-13
• Study Completion: 2015-03-13
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The electrical signal mean amplitude (mv) during AV synchronous pacing.	2 minutes during the procedure

Trial Locations

Locations (2)

Allgemeines Krankenhaus der Stadt Linz; 🇦🇹 Linz, Austria

Hôpital Cardiologique du Haut-Lévêque; 🇫🇷 Bordeaux, France