This trial is active, not recruiting.

Condition heart failure
Sponsor Medtronic
Start date March 2009
End date July 2019
Trial size 1322 participants
Trial identifier NCT00869921, 4195 Chronic Performance


Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Lead-related complication rate.
time frame: Implant to 5 years post-implant.

Secondary Outcomes

Types of Model 4195 lead-related events
time frame: 5 years post implant

Eligibility Criteria

Male or female participants of any age.

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria - Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements - Patient has or is intended to receive an Attain StarFix Model 4195 LV lead - Patient within 30 day post implant enrollment window Exclusion Criteria - Patient who is, or is expected to be inaccessible for follow-up - Patient with exclusion criteria required by local law - Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Additional Information

Official title Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Description Model 4195 LV lead complication-free survivability will be summarized.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic.