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Completed

NCT Number: NCT03723265

Personalized CRT - PSR

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Leuven, Belgium

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About this study

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.

Who can participate

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

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 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

Treatment and study plan

cardiac resynchronization therapy

Device

Primary outcomes

  1. CRT Response

    Time frame: Every 3-9 months

    A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.

Secondary outcomes

  1. Treatments for CRT non-response

    Time frame: Every 3-9 months

    Summary statistics will be obtained to describe the distribution of different treatments (or no treatment) the patient receives.

  2. Treatment effects for different CRT features in the CRT non-responder population

    Time frame: Every 3-9 months

    A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response.

  3. Patient outcome post initial CRT implant

    Time frame: Every 3-9 months

    Patient outcome will be measured as the patient first occurrence of HF related hospitalization or death.

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Personalized CRT - Product Surveillance Registry (PSR)

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2018
Registry last updated
May 20, 2022

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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