Heart Failure
Conditions
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.
Interventions
DEVICEdiagnostic electrophysiology catheter
electrical measurements through a diagnostic electrophysiology catheter
Sponsors
Medtronic Italia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of electrode property on phrenic nerve stimulation (PNS) | at implant | Effect of electrode property on PNS in the cardiac veins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed