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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00763698

Run by

Abbott Medical Devices

People needed

86

Starts

2008-10-01

Expected to finish

2010-05-01

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Approved indication for CRT-D system

You may not qualify if…

• Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
• Previous left ventricular (LV) lead implant
• Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment

Where it is running

• University Hospital-University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Glendale Memorial Hospital and Medical Center — Glendale, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• St. John Hospital and Medical Center — Detroit, Michigan, United States
• Thoracic Cardiovascular Healthcare Foundation — Lansing, Michigan, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• St. Francis Hospital — Roslyn, New York, United States
• EMH Regional Medical Center — Elyria, Ohio, United States
• St. Thomas Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.