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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00763698
First received: September 29, 2008
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Heart Failure
 Device: QuickFlex Micro Model 1258T Left Heart Lead

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QuickFlex Micro Model 1258T Left Heart Pacing Lead

Resource links provided by NLM:

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

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom From Left Ventricular Lead-related Complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Successful Left Ventricular Lead Implants [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Left Ventricular Bipolar Pacing Capture Threshold (Volts) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763698

Locations
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
Investigators
Study Director: Tamara Shipman St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00763698     History of Changes
Other Study ID Numbers: CRD 435
Study First Received: September 29, 2008
Results First Received: July 26, 2011
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Menthol
 Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013