PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study (PING-EP)

October 6, 2010 updated by: Medtronic Italia
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
      • Firenze, Italy, 50141
        • Azienda Ospedaliero-Universitaria Careggi
      • Rovigo, Italy, 45100
        • Ospedale S. Maria Della Misericordia
    • Venezia
      • Mirano, Venezia, Italy, 30035
        • Azienda Unità Socio Sanitaria di Dolo Mirano

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:

  • Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead
  • Patient has signed and dated the study-specific Patient Informed Consent form
  • Subject is at least 18 years of age

Exclusion Criteria:

  • Patient has a previous LV lead implanted not requiring repositioning
  • Pregnant woman
  • Patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of electrode property on phrenic nerve stimulation (PNS)
Time Frame: at implant
Effect of electrode property on PNS in the cardiac veins
at implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of electrode configuration on phrenic nerve stimulation (PNS)
Time Frame: at implant
at implant
Electrode polarity effect on phrenic nerve stimulation (PNS)
Time Frame: at implant
at implant
Effect of electrode property on sensing (r-wave amplitude)
Time Frame: at implant
at implant
Incidence of phrenic nerve stimulation (PNS) in the cardiac veins
Time Frame: at implant
Incidence of PNS occurrence in different locations in the cardiac vein
at implant

Collaborators and Investigators

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

Sponsor

Medtronic Italia

Investigators

  • Principal Investigator: Mauro Biffi, Policlinico S. Orsola Malpighi, Bologna, Italy
  • Principal Investigator: Francesco Zanon, Ospedale S. Maria della Misericordia, Rovigo, Italy
  • Principal Investigator: Luigi Padeletti, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy
  • Principal Investigator: Manuel Bertaglia, Azienda Unità Socio Sanitaria di Dolo Mirano, Mirano (VE), Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 22, 2010

First Posted (Estimate)

April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

October 7, 2010

Last Update Submitted That Met QC Criteria

October 6, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT-PINGEP

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.

Clinical Trials on Heart Failure

Clinical Trials on diagnostic electrophysiology catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe