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

Medtronic Italia4 sites in 1 country40 target enrollmentFebruary 2010

ConditionsHeart Failure

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medtronic Italia
Enrollment: 40
Locations: 4
Primary Endpoint: Effect of electrode property on phrenic nerve stimulation (PNS)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

October 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Italia

Eligibility 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

Outcomes

Primary Outcomes

Effect of electrode property on phrenic nerve stimulation (PNS)

Time Frame: at implant

Effect of electrode property on PNS in the cardiac veins

Secondary Outcomes

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)