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Completed

NCT Number: NCT01109641

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic electrophysiology catheter

Device

electrical measurements through a diagnostic electrophysiology catheter

Primary outcomes

  1. 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

  1. Effect of electrode configuration on phrenic nerve stimulation (PNS)

    Time frame: at implant

  2. Electrode polarity effect on phrenic nerve stimulation (PNS)

    Time frame: at implant

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

    Time frame: at implant

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

    Time frame: at implant

    Incidence of PNS occurrence in different locations in the cardiac vein

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Medtronic Italia

Industry

Registry information

Acronym: PING-EP

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 23, 2010
Registry last updated
Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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