NCT00763698

Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

QuickFlex Micro Model 1258T Left Heart Pacing Lead

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

Detailed description

The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device. Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	QuickFlex Micro Model 1258T Left Heart Lead	Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2010-05-01
• First posted: 2008-10-01
• Last updated: 2019-02-19
• Results posted: 2011-11-04

Locations

13 sites across 1 country: United States