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: July 17, 2013
Last verified: July 2013
  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 ] [ Designated as safety issue: Yes ]
  • LV lead electrical performance [ Time Frame: 5 years period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • LV Lead Bipolar Capture Threshold [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1884
Study Start Date: August 2010
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179477

Locations
United States, Indiana
Parkview Research Center
Fort Wayne, Indiana, United States, 46805
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: NCT01179477     History of Changes
Other Study ID Numbers: CRD561
Study First Received: August 9, 2010
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014