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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02326519
• Collaborator: (none)
• Enrollment: 31
• Locations: 2
• Arm: 1
• Actual Duration (Months): 17.3
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmias	Other: Intracardiac electrode catheter	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 13, 2015
• Actual Study Completion Date: Mar 13, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Intracardiac electrode catheter All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter.	Other: Intracardiac electrode catheter; All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter

Outcome Measures

Primary Outcome Measures

1. The electrical signal mean amplitude (mv) during AV synchronous pacing. [2 minutes during the procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allgemeines Krankenhaus der Stadt Linz	Linz		Austria
2	Hôpital Cardiologique du Haut-Lévêque	Bordeaux		France

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02326519
• Other Study ID Numbers: E20PC study
• First Posted: Dec 29, 2014
• Last Update Posted: Dec 20, 2017
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Dec 20, 2017