NCT01484613

Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads

Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 337 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads. Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.

Detailed description

Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria: 1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold 2. LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	quadripolar LV lead (Quartet)	All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-12-02
• Last updated: 2019-02-04

Locations

16 sites across 1 country: Germany