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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Annecy
  • Hopital Henri Mondor
  • CH LENS
  • CH de Bretagne Sud
  • Clinique Clairval
  • CHP Beauregard
  • Clinique Montpellier
  • Polyclinique de Gentilly
  • CHU Groupe Hospitalo-universitaire Caremeau
  • Hopital de La Source
  • CH St Joseph
  • Clinique St Pierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Resynchronization Therapy-Defibrillator

Arm Description

Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2016
Last Updated
April 24, 2017
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT03127202
Brief Title
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Acronym
ORPHEE
Official Title
Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Resynchronization Therapy-Defibrillator
Arm Type
Experimental
Arm Description
Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)
Intervention Description
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 Outcome Measure Information:
Title
Phrenic nerve stimulation measurement
Description
The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer
Time Frame
The presence of phrenic nerve stimulation will be assessed at implant.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri BENKEMOUN
Organizational Affiliation
Clinique Saint Pierre - Perpignan
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Annecy
City
Annecy
Country
France
Facility Name
Hopital Henri Mondor
City
Créteil
Country
France
Facility Name
CH LENS
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CH de Bretagne Sud
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Clinique Clairval
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
CHP Beauregard
City
Marseille
ZIP/Postal Code
13012
Country
France
Facility Name
Clinique Montpellier
City
Montpellier
Country
France
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
CHU Groupe Hospitalo-universitaire Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital de La Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
CH St Joseph
City
Paris
Country
France
Facility Name
Clinique St Pierre
City
Perpignan
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

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