Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00869921

Enrollment

1322

Registered

2009-03-26

Start date

2009-03-31

Completion date

2018-04-03

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Lead-related complication rate.	Implant to 5 years post-implant.

Secondary

Measure	Time frame
Types of Model 4195 lead-related events	5 years post implant

Countries

Canada, United Kingdom, United States

Outcome results