Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

Medtronic

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT00869921

4195 Chronic Performance

Details and patient eligibility

About

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.

Full description

Model 4195 LV lead complication-free survivability will be summarized.

Enrollment: 1,322 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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