Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Study Overview
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Brief Summary
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Evaluation of three left ventricular pacing polarities effectiveness to narrow phrenic nerve stimulation.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Resynchronization Therapy-Defibrillator<br>Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator | Device: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phrenic nerve stimulation measurement | The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer | The presence of phrenic nerve stimulation will be assessed at implant. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy