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

Heart Failure Clinical Trial

— PING-EP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109641
• Other study ID #: MDT-PINGEP
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: October 6, 2010
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Medtronic Italia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi	Bologna
Italy	Azienda Ospedaliero-universitaria Careggi	Firenze
Italy	Azienda Unità Socio Sanitaria di Dolo Mirano	Mirano	Venezia
Italy	Ospedale S. Maria della Misericordia	Rovigo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Italia

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. Epub 2007 May 21. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of electrode property on phrenic nerve stimulation (PNS)	Effect of electrode property on PNS in the cardiac veins	at implant	No
Secondary	Effect of electrode configuration on phrenic nerve stimulation (PNS)		at implant	No
Secondary	Electrode polarity effect on phrenic nerve stimulation (PNS)		at implant	No
Secondary	Effect of electrode property on sensing (r-wave amplitude)		at implant	No
Secondary	Incidence of phrenic nerve stimulation (PNS) in the cardiac veins	Incidence of PNS occurrence in different locations in the cardiac vein	at implant	No