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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Device: diagnostic electrophysiology catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109641

MDT-PINGEP

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)