PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study - Full Text View

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

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:

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:

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. Review.

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.

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.

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.

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.

Ellery S, Paul V, Prenner G, Tscheliessnigg K, Merkely B, Malinowski K, Fröhlig 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.

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. Epub 2007 May 21.


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

ClinicalTrials.gov processed this record on March 03, 2015