Arrhythmias, CardiacNCT05061862
Cardiac Implantable Electronic Device (CIED) Research Study
An observational study of Arrhythmias, Cardiac and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- What is being tested?
- cardiac implantable electronic devices (CIEDs)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 6 Mar 2022to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who meet all inclusion criteria and none of the exclusion criteria
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Inova Fairfax Hospital
Falls Church, Virginia, 22042
The Cardiac & Vascular Institute
Gainesville, Florida, 32605
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Georgia Arrhythmia Consultants
Macon, Georgia, 31201
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University Hospital
Portland, Oregon, 97239
About this 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.
Read the detailed description
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
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- Being tested
- cardiac implantable electronic devices (CIEDs)
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| CIED Indicated Subjects | Subjects indicated to receive a cardiac implantable electronic devices (CIEDs) Receives: Device: cardiac implantable electronic devices (CIEDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product Development
Characterize Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details and/or patient characteristics to support development of future CIED products and procedures.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start6 Mar 2022
- Primary completion31 Oct 2025
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061862
- Sponsor's protocol ID
- CIED Research Study
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2021
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Implantable Electronic Device (CIED) Research Study
- ClinicalTrials.gov ID
- NCT05061862
- Acronym / sponsor ID
- CIED Research Study
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIED Indicated Subjects | – | Device: cardiac implantable electronic devices (CIEDs)Subjects indicated to receive a cardiac implantable electronic devices (CIEDs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who meet all inclusion criteria and none of the exclusion criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | CIED Indicated Subjects |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product Development (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.