This trial is active, not recruiting.

Condition heart failure
Treatment implantation of a quickflex® μ model 1258t lv lead
Phase phase 4
Sponsor St. Jude Medical
Start date August 2010
End date August 2017
Trial size 1930 participants
Trial identifier NCT01179477, CRD561


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Complication free survival rate at 5 years for complications related to the left ventricular lead
time frame: 5 years
LV lead electrical performance
time frame: 5 years period

Secondary Outcomes

LV Lead Bipolar Capture Threshold
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.