Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

LivaNova90 enrolled

Overview

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

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

CH Annecy

Annecy, France

Hopital Henri Mondor

Créteil, France

CH LENS

Lens, France

CH de Bretagne Sud

Lorient, France

Outcomes

Primary Outcomes

Phrenic nerve stimulation measurement

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.

Data from ClinicalTrials.gov

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