Clinical trial NCT03127202: Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Official title: Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Phrenic nerve stimulation measurement
timeFrame: The presence of phrenic nerve stimulation will be assessed at implant.
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lens
country: France
facility: CH LENS
city: Lorient
country: France
facility: CH de Bretagne Sud
city: Marseille
country: France
facility: Clinique Clairval
city: Marseille
country: France
facility: CHP Beauregard
city: Montpellier
country: France
facility: Clinique Montpellier
city: Nancy
country: France
facility: Polyclinique de Gentilly
city: Nimes
country: France
facility: CHU Groupe Hospitalo-universitaire Caremeau
city: Orleans
country: France
facility: Hopital de La Source
city: Paris
country: France
facility: CH St Joseph
city: Perpignan
country: France
facility: Clinique St Pierre
Study officials:
affiliation: Clinique Saint Pierre - Perpignan
name: Henri BENKEMOUN
role: PRINCIPAL_INVESTIGATOR
References: