Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Medtronic1,140 enrolled

Overview

Lead survivability will be summarized.

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.

Study Type

OBSERVATIONAL

Enrollment

1,140

Conditions

Heart Failure

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (99)

Outcomes

Primary Outcomes

Model 4296 LV Lead-related complication rate

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

Time frame: 5 years

Secondary Outcomes

Types of lead-related adverse device effects

To summarize all lead related adverse events

Time frame: 5 years

Percent of subjects with changes in electrode programming

To characterize any changes in electrical programming

Time frame: 5 years

Number of fractures with and without loss of function

To characterize fractures with and without loss of function

Time frame: 5 years

Bipolar electrical performance at 1 year

To summarize bipolar electrical performance at one year post implant

Time frame: 1 year

Bipolar pacing impedance

To characterize threshold measurements and impedance for both conductors

Time frame: 1 year

Bipolar pacing capture threshold

To characterize standard bipolar pacing voltage thresholds

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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Monterey, California, United States

...and 89 more locations