PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study (PING-EP)
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ClinicalTrials.gov Identifier: NCT01109641 |
Recruitment Status
:
Completed
First Posted
: April 23, 2010
Last Update Posted
: October 7, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Device: diagnostic electrophysiology catheter | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |
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Device: diagnostic electrophysiology catheter
- Effect of electrode property on phrenic nerve stimulation (PNS) [ Time Frame: at implant ]Effect of electrode property on PNS in the cardiac veins
- 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

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109641
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 |
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:
Responsible Party: | Francesco De Seta, Medtronic Italia |
ClinicalTrials.gov Identifier: | NCT01109641 History of Changes |
Other Study ID Numbers: |
MDT-PINGEP |
First Posted: | April 23, 2010 Key Record Dates |
Last Update Posted: | October 7, 2010 |
Last Verified: | October 2010 |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |