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

This study has been completed.
Sponsor:
Information provided by:
Medtronic Italia
ClinicalTrials.gov Identifier:
NCT01109641
First received: April 21, 2010
Last updated: October 6, 2010
Last verified: October 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

Resource links provided by NLM:


Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • Effect of electrode property on phrenic nerve stimulation (PNS) [ Time Frame: at implant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Electrode polarity effect on phrenic nerve stimulation (PNS) [ Time Frame: at implant ] [ Designated as safety issue: No ]
  • Effect of electrode property on sensing (r-wave amplitude) [ Time Frame: at implant ] [ Designated as safety issue: No ]
  • Incidence of phrenic nerve stimulation (PNS) in the cardiac veins [ Time Frame: at implant ] [ Designated as safety issue: No ]
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109641

Locations
Italy
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
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
  More Information

Publications:

Responsible Party: Francesco De Seta, Medtronic Italia
ClinicalTrials.gov Identifier: NCT01109641     History of Changes
Other Study ID Numbers: MDT-PINGEP
Study First Received: April 21, 2010
Last Updated: October 6, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014