Personalized CRT - PSR

  • STATUS
    Recruiting
  • End date
    Jan 16, 2024
  • participants needed
    15000
  • sponsor
    Medtronic
Updated on 16 September 2020
Investigator
Micra Registry Manager
Primary Contact
(4.3 mi away) Contact
+119 other location
cardiac resynchronization therapy

Summary

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Description

The Personalized CRT study is a multi-center, single arm, prospective observational study. The purpose of the study is to better understand and characterize heart failure (HF) patient management by characterizing the use and clinical benefit of Medtronic market-released features/tools within the HF Patient Management portfolio.

Details
Treatment Cardiac Resynchronization Therapy
Clinical Study IdentifierNCT03723265
SponsorMedtronic
Last Modified on16 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Heart disease or Cardiac Disease or Congestive Heart Failure or Heart failure?
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible CRT device
Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

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
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Step 2 Get screened

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

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Step 3 Enroll in the clinical study

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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Step 4 Get your study results

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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