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QuickFlex Micro Post Approval Study (QuickFlex PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01179477
First received: August 9, 2010
Last updated: December 18, 2012
Last verified: December 2012
History of Changes

August 9, 2010
December 18, 2012
August 2010
March 2017   (final data collection date for primary outcome measure)
  • Complication free survival rate at 5 years for complications related to the left ventricular lead [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • LV lead electrical performance [ Time Frame: 5 years period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01179477 on ClinicalTrials.gov Archive Site
LV Lead Bipolar Capture Threshold [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
QuickFlex Micro Post Approval Study
QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

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

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system
Heart Failure
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1884
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01179477
CRD561
No
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Tamara Shipman St. Jude Medical
St. Jude Medical
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP