Clinical trial NCT00763698: Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
Official title: QuickFlex Micro Model 1258T Left Heart Pacing Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart failure
ICD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-10-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Approved indication for CRT-D system

Exclusion Criteria:

* 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

Primary outcomes:
measure: Freedom From Left Ventricular Lead-related Complications
timeFrame: 3 months
measure: Percentage of Successful Left Ventricular Lead Implants
timeFrame: 3 months
measure: Left Ventricular Bipolar Pacing Capture Threshold (Volts)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital-University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardiovascular Healthcare Foundation
state: Michigan
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
Study officials:
affiliation: Abbott Medical Devices
name: Tamara Shipman
role: STUDY_DIRECTOR
References: