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OpenTrials
Active, Not Recruiting

NCT Number: NCT05061862

Cardiac Implantable Electronic Device (CIED) Research Study

The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven - Campus Gasthuisberg, Leuven, Belgium

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About this study

This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Who can participate

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

Inclusion criteria

  • Subject is at least 18 years of age.
  • Subject is willing and able to provide written informed consent.
  • Subject is willing and able to complete the study procedures and visits for the duration of data collection requirements

Exclusion criteria

  • Subject is unwilling or unable to comply with study procedures as defined in the protocol.
  • Subject with a medical condition that precludes the patient from participation in the opinion of the investigator.
  • Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.

Treatment and study plan

cardiac implantable electronic devices (CIEDs)

Device

Subjects will be implanted with various cardiac implantable electronic devices and followed according to their standard of care. Medical imaging will be collected at various stages of the implant procedure and/or non-invasive diagnostic collection at follow-up visits, as applicable.

Primary outcomes

  1. Product Development

    Time frame: 3 years

    Characterize Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details and/or patient characteristics to support development of future CIED products and procedures.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 30, 2021
Registry last updated
Dec 10, 2025

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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