Cardiac Implantable Electronic Device (CIED) Research Study
1 other identifier
observational
1,000
2 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedStudy Start
First participant enrolled
March 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedDecember 10, 2025
December 1, 2025
3.7 years
September 20, 2021
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 years
Study Arms (1)
CIED Indicated Subjects
Subjects indicated to receive a cardiac implantable electronic devices (CIEDs)
Interventions
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.
Eligibility Criteria
Subjects who meet all inclusion criteria and none of the exclusion criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Cardiac & Vascular Institute
Gainesville, Florida, 32605, United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2021
First Posted
September 30, 2021
Study Start
March 6, 2022
Primary Completion
October 31, 2025
Study Completion
May 1, 2026
Last Updated
December 10, 2025
Record last verified: 2025-12