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Completed

NCT Number: NCT00869921

Model 4195 Left Ventricular (LV) Lead Chronic Performance Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lead-related complication rate.

    Time frame: Implant to 5 years post-implant.

Secondary outcomes

  1. Types of Model 4195 lead-related events

    Time frame: 5 years post implant

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2009
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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