Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03127202

Acronym

ORPHEE

Enrollment

Registered

2017-04-25

Start date

2012-11-30

Completion date

2015-12-31

Last updated

2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy

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.

Interventions

DEVICECardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026