Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation (ORPHEE)

April 24, 2017 updated by: LivaNova

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • CH Annecy
      • Créteil, France
        • Hopital Henri Mondor
      • Lens, France, 62307
        • CH LENS
      • Lorient, France, 56322
        • CH de Bretagne Sud
      • Marseille, France, 13012
        • CHP Beauregard
      • Marseille, France, 13000
        • Clinique Clairval
      • Montpellier, France
        • Clinique Montpellier
      • Nancy, France, 54100
        • Polyclinique de Gentilly
      • Nimes, France, 30029
        • CHU Groupe Hospitalo-universitaire Caremeau
      • Orleans, France, 45067
        • Hôpital de la Source
      • Paris, France
        • CH St Joseph
      • Perpignan, France
        • Clinique St Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Resynchronization Therapy-Defibrillator
Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator
Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The presence of phrenic nerve stimulation will be assessed at implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Henri BENKEMOUN, Clinique Saint Pierre - Perpignan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTSY01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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