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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

Tracking Information
First Submitted Date August 9, 2010
First Posted Date August 11, 2010
Results First Submitted Date November 6, 2018
Results First Posted Date August 12, 2019
Last Update Posted Date August 12, 2019
Actual Study Start Date September 2010
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • 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).
  • 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
Original Primary Outcome Measures
 (submitted: August 9, 2010)
  • Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ]
  • Electrical performance [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title QuickFlex Micro Left Ventricular Lead Post Approval Study
Official Title QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
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.
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with an approved indication for implantation of a CRT-D system
Condition Heart Failure
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 9, 2014)
1930
Original Estimated Enrollment
 (submitted: August 9, 2010)
1884
Actual Study Completion Date September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01179477
Other Study ID Numbers CRD561
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Director: Clay Cohorn Abbott Medical Devices
PRS Account Abbott Medical Devices
Verification Date July 2019