Clinical trial NCT01109641: PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
Official title: PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Medtronic Italia
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Effect of electrode property on phrenic nerve stimulation (PNS)
timeFrame: at implant
Secondary outcomes:
measure: Effect of electrode configuration on phrenic nerve stimulation (PNS)
timeFrame: at implant
measure: Electrode polarity effect on phrenic nerve stimulation (PNS)
timeFrame: at implant
measure: Effect of electrode property on sensing (r-wave amplitude)
timeFrame: at implant
measure: Incidence of phrenic nerve stimulation (PNS) in the cardiac veins
timeFrame: at implant
Other outcomes:
Locations:
city: Mirano
country: Italy
facility: Azienda Unità Socio Sanitaria di Dolo Mirano
state: Venezia
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliero-universitaria Careggi
city: Rovigo
country: Italy
facility: Ospedale S. Maria della Misericordia
Study officials:
affiliation: Policlinico S. Orsola Malpighi, Bologna, Italy
name: Mauro Biffi
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale S. Maria della Misericordia, Rovigo, Italy
name: Francesco Zanon
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda ospedaliero-universitaria Careggi, Firenze, Italy
name: Luigi Padeletti
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Unità Socio Sanitaria di Dolo Mirano, Mirano (VE), Italy
name: Manuel Bertaglia
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.
citation: Gurevitz O, Nof E, Carasso S, Luria D, Bar-Lev D, Tanami N, Eldar M, Glikson M. Programmable multiple pacing configurations help to overcome high left ventricular pacing thresholds and avoid phrenic nerve stimulation. Pacing Clin Electrophysiol. 2005 Dec;28(12):1255-9. doi: 10.1111/j.1540-8159.2005.00265.x.
citation: Albertsen AE, Nielsen JC, Pedersen AK, Hansen PS, Jensen HK, Mortensen PT. Left ventricular lead performance in cardiac resynchronization therapy: impact of lead localization and complications. Pacing Clin Electrophysiol. 2005 Jun;28(6):483-8. doi: 10.1111/j.1540-8159.2005.40066.x.
citation: Alonso C, Leclercq C, d'Allonnes FR, Pavin D, Victor F, Mabo P, Daubert JC. Six year experience of transvenous left ventricular lead implantation for permanent biventricular pacing in patients with advanced heart failure: technical aspects. Heart. 2001 Oct;86(4):405-10. doi: 10.1136/heart.86.4.405.
citation: Knight BP, Desai A, Coman J, Faddis M, Yong P. Long-term retention of cardiac resynchronization therapy. J Am Coll Cardiol. 2004 Jul 7;44(1):72-7. doi: 10.1016/j.jacc.2004.03.054.
citation: Ellery S, Paul V, Prenner G, Tscheliessnigg K, Merkely B, Malinowski K, Frohlig G, Hintringer F, Bosse O, Diotallevi P, Ravazzi AP, Flathmann H, Danilovic D, Unterberg-Buchwald C; OVID Study Investigators. A new endocardial "over-the-wire" or stylet-driven left ventricular lead: first clinical experience. Pacing Clin Electrophysiol. 2005 Jan;28 Suppl 1:S31-5. doi: 10.1111/j.1540-8159.2005.00084.x.
citation: Matsumoto Y, Krishnan S, Fowler SJ, Saremi F, Kondo T, Ahsan C, Narula J, Gurudevan S. Detection of phrenic nerves and their relation to cardiac anatomy using 64-slice multidetector computed tomography. Am J Cardiol. 2007 Jul 1;100(1):133-7. doi: 10.1016/j.amjcard.2007.01.072. Epub 2007 May 21.