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
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, see Learn About Clinical Studies.

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 July 22, 2014