Evaluation of Left Ventricular Pacing Vectors Use in Phrenic Nerve Stimulation Management and Left Ventricular Parameters Adjustment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LivaNova
- Enrollment
- 90
- Locations
- 12
- Primary Endpoint
- Phrenic nerve stimulation measurement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cardiac Resynchronization Therapy-Defibrillator
Eligible patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator
Intervention: Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France) (Device)
Outcomes
Primary Outcomes
Phrenic nerve stimulation measurement
Time Frame: The presence of phrenic nerve stimulation will be assessed at implant.
The presence of phrenic nerve stimulation at 10 Volt, using a pacing system analyzer
Secondary Outcomes
No secondary outcomes reported