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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00763698
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : November 4, 2011
Last Update Posted : November 4, 2011
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment
Heart Failure Device: QuickFlex Micro Model 1258T Left Heart Lead

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QuickFlex Micro Model 1258T Left Heart Pacing Lead
Study Start Date : October 2008
Primary Completion Date : June 2009
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Menthol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: QuickFlex micro 1258T left heart lead Device: QuickFlex Micro Model 1258T Left Heart Lead
Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.
Other Name: Model 1258T left heart pacing lead

Primary Outcome Measures :
  1. Freedom From Left Ventricular Lead-related Complications [ Time Frame: 3 months ]
    A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.

  2. Percentage of Successful Left Ventricular Lead Implants [ Time Frame: 3 months ]
    Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.

  3. Left Ventricular Bipolar Pacing Capture Threshold (Volts) [ Time Frame: 3 months ]
    The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00763698

United States, Alabama
University Hospital-University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Glendale Memorial Hospital and Medical Center
Glendale, California, United States, 91204
Regional Cardiology Associates
Sacramento, California, United States, 95819
United States, Illinois
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
United States, New York
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, Ohio
EMH Regional Medical Center
Elyria, Ohio, United States, 44035
United States, Tennessee
St. Thomas Hospital
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
St. Jude Medical
Study Director: Tamara Shipman St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT00763698     History of Changes
Other Study ID Numbers: CRD 435
First Posted: October 1, 2008    Key Record Dates
Results First Posted: November 4, 2011
Last Update Posted: November 4, 2011
Last Verified: September 2011

Keywords provided by St. Jude Medical:
Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dermatologic Agents