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

LivaNova

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03127202

RTSY01

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Cardiac Resynchronization Therapy-Defibrillator

Experimental group

Description:

Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator

Treatment:

Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)