NCT00819117

Investigation of Transvenous Versus Epicardial Left Ventricular Stimulation Technique

INvestigation of TRansvenous Versus EPIcarDial Left Ventricular Stimulation Technique

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

Detailed description

This clinical trial is a multicenter, prospective, randomized, parallel, open study designed to compare epicardial left ventricular pacing to transvenous left ventricular pacing for delivering cardiac resynchronization therapy. After a pre-implant baseline evaluation, patients will be randomized in a 1:1 fashion to one of two groups: * Control group: resynchronization via a transvenous left ventricular lead (TVN CRT); * Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT). All patients taking part in this study will undergo the implantation of a CRT device with or without ICD back-up (depending on the physician's decision), with right atrial and right ventricular transvenous leads. Patients will attend protocol scheduled visits before implant (pre-implant baseline evaluation), and post-implant: before hospital discharge, 6 weeks post-implant (optional visit), 3 months (optional visit), and 6 months after implant, time of study termination.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy implant	Device implant with appropriate leads

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-01-08
• Last updated: 2019-02-04

Locations

2 sites across 1 country: Italy