NCT03127202

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2017-04-25
• Last updated: 2017-04-25

Locations

12 sites across 1 country: France