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QuickFlex Micro Left Ventricular Lead Post Approval Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179477
First Posted: August 11, 2010
Last Update Posted: July 20, 2016
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.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular lead.

Condition Intervention Phase
Heart Failure Device: Implantation of a QuickFlex® μ Model 1258T LV Lead Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ]
  • LV lead electrical performance [ Time Frame: 5 years period ]

Secondary Outcome Measures:
  • LV Lead Bipolar Capture Threshold [ Time Frame: 5 years ]

Enrollment: 1930
Study Start Date: August 2010
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantation of a QuickFlex® μ Model 1258T LV Lead
    Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead
    Other Name: LV pacing lead
Detailed Description:

The endpoints of the study are:

  • Complication free survival rate at 5 years for complications related to the LV lead
  • Electrical performance (capture threshold) of St. Jude Medical's QuickFlex®µ 1258T LV Lead
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system
Criteria

Inclusion Criteria:

  • Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T IDE study
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Have a life expectancy of less than 5 years due to any condition
  • Be less than 18 years of age
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01179477


  Show 77 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Clay Cohorn St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01179477     History of Changes
Other Study ID Numbers: CRD561
First Submitted: August 9, 2010
First Posted: August 11, 2010
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Menthol
Antipruritics
Dermatologic Agents