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OpenTrials
Completed

NCT Number: NCT03127202

Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy, Annecy, France

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About this study

The primary endpoint of the study aims at demonstrating that the three left ventricular polarities in the Cardiac Resynchronisation Therapy-Defibrillator could bypass phrenic nerve stimulation at least in 90% of implants.

Success was defined as an absence of phrenic nerve stimulation (threshold > 7V) or in case of phrenic nerve stimulation occurrence (threshold < 7V), as the resolution of the phrenic nerve stimulation by reprogramming one of the 3 left ventricular pacing polarities available in the device : left ventricular tip- left ventricular ring (bipolar), left ventricular tip- right ventricular ring (pseudo-bipolar) and left ventricular ring-right ventricular coil.

Any occurrence of phrenic nerve stimulation without resolution by reprogramming was considered as a failure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible for an implantation of a Cardiac Resynchronization Therapy-Defibrillator according to relevant regulations (will be only tolerated primo-implantation and upgrade)
  • Patient scheduled for implantation of a Cardiac Resynchronization Therapy-Defibrillator
  • Patient has given his informed consent

Exclusion criteria

  • Any contraindication for Implantable Cardioverter Defibrillator therapy
  • Heart transplantation or waiting for heart transplantation
  • Implanted with a ventricular assist device (VAD)
  • Inability to understand the purpose of the study or to cooperate
  • Not available for routine follow-up visits
  • Life expectancy less than 12 months
  • Age of less than 18 years and et pregnancy
  • Under guardianship

Treatment and study plan

Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)

Device

Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion.

Primary outcomes

  1. Phrenic nerve stimulation measurement

    Time frame: The presence of phrenic nerve stimulation will be assessed at implant.

    The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Registry information

Official study title

Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment

Acronym: ORPHEE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2017
Registry last updated
Apr 25, 2017

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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