Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation

Heart Failure Clinical Trial

— ORPHEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127202
• Other study ID #: RTSY01
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: April 24, 2017
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	CH Annecy	Annecy
France	Hopital Henri Mondor	Créteil
France	CH LENS	Lens
France	CH de Bretagne Sud	Lorient
France	CHP Beauregard	Marseille
France	Clinique Clairval	Marseille
France	Clinique Montpellier	Montpellier
France	Polyclinique de Gentilly	Nancy
France	CHU Groupe Hospitalo-universitaire Caremeau	Nimes
France	Hopital de La Source	Orleans
France	CH St Joseph	Paris
France	Clinique St Pierre	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.