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QuickFlex Micro Left Ventricular Lead Post Approval Study

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.
 
ClinicalTrials.gov Identifier: NCT01179477
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

Condition or disease Intervention/treatment
Heart Failure Device: Implantation of a QuickFlex® μ Model 1258T LV Lead

Detailed Description:

The primary endpoints of the study are:

  • Freedom from LV lead-related complications at 5 years
  • LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years

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Study Type : Observational
Actual Enrollment : 1930 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
Actual Study Start Date : September 2010
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Menthol


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


Primary Outcome Measures :
  1. Percent of Participants Alive and Without a Left Ventricular Lead-related Complication [ Time Frame: 5 years ]
    Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).

  2. Left Ventricular Bipolar Pacing Capture Threshold [ Time Frame: 5 years ]
    Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (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

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


Locations
Show Show 77 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Clay Cohorn Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] June 10, 2010
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01179477    
Other Study ID Numbers: CRD561
First Posted: August 11, 2010    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents