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

December 18, 2017 updated by: Medtronic Cardiac Rhythm and Heart Failure
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Allgemeines Krankenhaus der Stadt Linz
  • France
      • Bordeaux, France
        • Hôpital Cardiologique Du Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The electrical signal mean amplitude (mv) during AV synchronous pacing.
Time Frame: 2 minutes during the procedure
2 minutes during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 13, 2015

Study Completion (Actual)

March 13, 2015

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 29, 2014

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20PC study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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