Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)

• Registration Number: NCT03127202
• Lead Sponsor: LivaNova

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-03-02
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac Resynchronization Therapy-Defibrillator	Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)	Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator

Primary Outcome Measures

Name	Time	Method
Phrenic nerve stimulation measurement	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

Trial Locations

Locations (12)

CH de Bretagne Sud; 🇫🇷 Lorient, France

Polyclinique de Gentilly; 🇫🇷 Nancy, France

CHP Beauregard; 🇫🇷 Marseille, France

CH St Joseph; 🇫🇷 Paris, France

CH Annecy; 🇫🇷 Annecy, France

CHU Groupe Hospitalo-universitaire Caremeau; 🇫🇷 Nimes, France

Hopital Henri Mondor; 🇫🇷 Créteil, France

CH LENS; 🇫🇷 Lens, France

Clinique Montpellier; 🇫🇷 Montpellier, France

Hopital de La Source; 🇫🇷 Orleans, France

Clinique St Pierre; 🇫🇷 Perpignan, France

Clinique Clairval; 🇫🇷 Marseille, France