A registry study of patients with defibrillators to observe how they are used and how effective the device is.

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

Study length: 6 years

Description

Details
Condition defibrillator, Cardiovascular Disease, Defibrillator (AICD)
Clinical Study IdentifierTX154757
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies
Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure
Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol

Exclusion Criteria

Subject with documented life expectancy of less than 12 months
Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device)
Subject who have had a pre-existing CRT device
Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager
Women of childbearing potential who are or might be pregnant at time of study enrollment
Any contra-indication to receive a CRT-D device per local guidelines
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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