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Completed

NCT Number: NCT01361672

Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Lead survivability will be summarized.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa, Ontario, Canada

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About this study

The purpose of this study is to evaluate long-term performance of the 4296 LV Lead. This evaluation is based on the number of lead-related complications occurring 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 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.

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 Ability Model 4296 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. Model 4296 LV Lead-related complication rate

    Time frame: 5 years

    To demonstrate that the Model 4296 lead-related complication-free probability

Secondary outcomes

  1. Types of lead-related adverse device effects

    Time frame: 5 years

    To summarize all lead related adverse events

  2. Percent of subjects with changes in electrode programming

    Time frame: 5 years

    To characterize any changes in electrical programming

  3. Number of fractures with and without loss of function

    Time frame: 5 years

    To characterize fractures with and without loss of function

  4. Bipolar electrical performance at 1 year

    Time frame: 1 year

    To summarize bipolar electrical performance at one year post implant

  5. Bipolar pacing impedance

    Time frame: 1 year

    To characterize threshold measurements and impedance for both conductors

  6. Bipolar pacing capture threshold

    Time frame: 1 year

    To characterize standard bipolar pacing voltage thresholds

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
May 27, 2011
Registry last updated
Jul 22, 2019

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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