Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
ORPHEE
Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
1 other identifier
interventional
90
1 country
12
Brief Summary
Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Nov 2012
Typical duration for not_applicable heart-failure
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedApril 25, 2017
April 1, 2017
3.1 years
March 2, 2016
April 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phrenic nerve stimulation measurement
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.
Study Arms (1)
Cardiac Resynchronization Therapy-Defibrillator
EXPERIMENTALEligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (12)
CH Annecy
Annecy, France
Hopital Henri Mondor
Créteil, France
CH LENS
Lens, 62307, France
CH de Bretagne Sud
Lorient, 56322, France
Clinique Clairval
Marseille, 13000, France
CHP Beauregard
Marseille, 13012, France
Clinique Montpellier
Montpellier, France
Polyclinique de Gentilly
Nancy, 54100, France
CHU Groupe Hospitalo-universitaire Caremeau
Nîmes, 30029, France
Hopital de La Source
Orléans, 45067, France
CH St Joseph
Paris, France
Clinique St Pierre
Perpignan, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henri BENKEMOUN
Clinique Saint Pierre - Perpignan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2016
First Posted
April 25, 2017
Study Start
November 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 25, 2017
Record last verified: 2017-04