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

NCT01109641 | Completed Phase 4

• 1 other identifier: MDT-PINGEP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Effect of electrode property on phrenic nerve stimulation (PNS)

  Effect of electrode property on PNS in the cardiac veins

  at implant

Secondary Outcomes (4)

• Effect of electrode configuration on phrenic nerve stimulation (PNS)

  at implant

• Electrode polarity effect on phrenic nerve stimulation (PNS)

  at implant

• Effect of electrode property on sensing (r-wave amplitude)

  at implant

• Incidence of phrenic nerve stimulation (PNS) in the cardiac veins

  at implant

Interventions

diagnostic electrophysiology catheter DEVICE

electrical measurements through a diagnostic electrophysiology catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Italia: lead

Study Sites (4)

Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi

Bologna, Bologna, 40138, Italy

Location

Azienda Ospedaliero-universitaria Careggi

Florence, Firenze, 50141, Italy

Location

Ospedale S. Maria della Misericordia

Rovigo, Rovigo, 45100, Italy

Location

Azienda Unità Socio Sanitaria di Dolo Mirano

Mirano, Venezia, 30035, Italy

Location

Related Publications (7)

• 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.

  PMID: 17565085 BACKGROUND

• 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.

  PMID: 16403156 BACKGROUND

• 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.

  PMID: 15955178 BACKGROUND

• 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.

  PMID: 11559679 BACKGROUND

• 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.

  PMID: 15234410 BACKGROUND

• 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.

  PMID: 15683519 BACKGROUND

• 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.

  PMID: 17599455 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 7, 2010

Record last verified: 2010-10

Locations

IT (4)