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

This study has been completed.
Information provided by:
Medtronic Italia Identifier:
First received: April 21, 2010
Last updated: October 6, 2010
Last verified: October 2010
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.

Condition Intervention Phase
Heart Failure
Device: diagnostic electrophysiology catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • Effect of electrode property on phrenic nerve stimulation (PNS) [ Time Frame: at implant ]
    Effect of electrode property on PNS in the cardiac veins

Secondary Outcome Measures:
  • Effect of electrode configuration on phrenic nerve stimulation (PNS) [ Time Frame: at implant ]
  • Electrode polarity effect on phrenic nerve stimulation (PNS) [ Time Frame: at implant ]
  • Effect of electrode property on sensing (r-wave amplitude) [ Time Frame: 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

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: diagnostic electrophysiology catheter
    electrical measurements through a diagnostic electrophysiology catheter

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01109641

Azienda Unità Socio Sanitaria di Dolo Mirano
Mirano, Venezia, Italy, 30035
Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliero-universitaria Careggi
Firenze, Italy, 50141
Ospedale S. Maria della Misericordia
Rovigo, Italy, 45100
Sponsors and Collaborators
Medtronic Italia
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
  More Information


Responsible Party: Francesco De Seta, Medtronic Italia Identifier: NCT01109641     History of Changes
Other Study ID Numbers: MDT-PINGEP
Study First Received: April 21, 2010
Last Updated: October 6, 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 23, 2017