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

Cardiac Arrhythmias Clinical Trial

— E20PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326519
• Other study ID #: E20PC study
• Status: Completed
• Phase: N/A
• First received: December 10, 2014
• Last updated: December 18, 2017
• Start date: October 1, 2013
• Est. completion date: March 13, 2015

Study information

• Verified date: December 2017
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 13, 2015
• Est. primary completion date: January 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Intervention

Other:
• Intracardiac electrode catheter
All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz
France	Hôpital Cardiologique du Haut-Lévêque	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Austria,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The electrical signal mean amplitude (mv) during AV synchronous pacing.		2 minutes during the procedure