Cardiac Implantable Electronic Device (CIED) Research Study

NCT ID: NCT05061862

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-06

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arrhythmias, Cardiac Bradycardia Tachycardia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CIED Indicated Subjects

Subjects indicated to receive a cardiac implantable electronic devices (CIEDs)

cardiac implantable electronic devices (CIEDs)

Intervention Type 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.

Interventions

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cardiac implantable electronic devices (CIEDs)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Cardiac & Vascular Institute

Gainesville, Florida, United States

Site Status

Georgia Arrhythmia Consultants

Macon, Georgia, United States

Site Status

Oregon Health & Science University Hospital

Portland, Oregon, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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CIED Research Study

Identifier Type: -

Identifier Source: org_study_id

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