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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2010

Interventions

  • Device: diagnostic electrophysiology catheter
    • electrical measurements through a diagnostic electrophysiology catheter

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Italia
  • Provider of Information About this Clinical Study
    • Francesco De Seta, Medtronic Italia
  • Overall Official(s)
    • Mauro Biffi, Principal Investigator, Policlinico S. Orsola Malpighi, Bologna, Italy
    • Francesco Zanon, Principal Investigator, Ospedale S. Maria della Misericordia, Rovigo, Italy
    • Luigi Padeletti, Principal Investigator, Azienda ospedaliero-universitaria Careggi, Firenze, Italy
    • Manuel Bertaglia, Principal Investigator, Azienda Unità Socio Sanitaria di Dolo Mirano, Mirano (VE), Italy

References

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.

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.

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.

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.

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.

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.

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.

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