Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-11 @ 10:40 PM
Study NCT ID:
NCT03127202
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2016-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Pacing Vectors Effectiveness to Narrow Phrenic Nerve Stimulation
Sponsor:
LivaNova
Organization:
Study Overview
Official Title:
Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORPHEE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: