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

Phase 4

Completed

• Conditions: Heart Failure

• Registration Number: NCT01109641
• Lead Sponsor: Medtronic Italia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-06
• Last Update Posted: 2010-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effect of electrode property on phrenic nerve stimulation (PNS)	at implant	Effect of electrode property on PNS in the cardiac veins

Secondary Outcome Measures

Name	Time	Method
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	Incidence of PNS occurrence in different locations in the cardiac vein

Trial Locations

Locations (4)

Azienda Unità Socio Sanitaria di Dolo Mirano; 🇮🇹 Mirano, Venezia, Italy

Azienda Ospedaliero-universitaria Careggi; 🇮🇹 Firenze, Italy

Azienda Ospedaliero-Universitana di Bologna, Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Ospedale S. Maria della Misericordia; 🇮🇹 Rovigo, Italy