Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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

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RECRUITING

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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cardiac Resynchronization Therapy-Defibrillator

Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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Cardiac 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No