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

Primary Purpose

Cardiac Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intracardiac electrode catheter
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Arrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Linz
  • Hôpital Cardiologique du Haut-Lévêque

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intracardiac electrode catheter

Arm Description

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

Outcomes

Primary Outcome Measures

The electrical signal mean amplitude (mv) during AV synchronous pacing.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2014
Last Updated
December 18, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02326519
Brief Title
Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
Acronym
E20PC
Official Title
Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
January 13, 2015 (Actual)
Study Completion Date
March 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmias

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracardiac electrode catheter
Arm Type
Other
Arm Description
All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter.
Intervention Type
Other
Intervention Name(s)
Intracardiac electrode catheter
Intervention Description
All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter
Primary Outcome Measure Information:
Title
The electrical signal mean amplitude (mv) during AV synchronous pacing.
Time Frame
2 minutes during the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
Country
Austria
Facility Name
Hôpital Cardiologique du Haut-Lévêque
City
Bordeaux
Country
France

12. IPD Sharing Statement

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

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