Research on cardiac implantable electronic devices
Cardiac Implantable Electronic Device (CIED) Research Study
This study is collecting information from people with heart devices to help improve future treatments and procedures for heart conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Rhythm and Heart Failure Industry-sponsored |
| Locations | 9 sites (Gainesville, Florida and 8 other locations) |
| Trial ID | NCT05061862 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on cardiovascular implantable electronic devices (CIEDs), including information about the implant procedures and patient characteristics. It will involve multiple independent cohorts, each with specific objectives and assessments. Participants will receive routine care while meeting the inclusion criteria and not having any exclusion criteria. The data collected will support the development of future CIED products and procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are receiving routine care for arrhythmias and are willing to participate.
Not a fit: Patients with medical conditions that prevent participation or those enrolled in conflicting studies may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved CIED products and procedures, enhancing patient care and outcomes.
How similar studies have performed: Other studies focusing on CIEDs have shown promise in improving device technology and patient outcomes, indicating a supportive background for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gainesville, Florida and 8 other locations
- The Cardiac & Vascular Institute — Gainesville, Florida, United States (Terminated)
- Georgia Arrhythmia Consultants — Macon, Georgia, United States (Terminated)
- Oregon Health & Science University Hospital — Portland, Oregon, United States (Not_yet_recruiting)
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Terminated)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Not_yet_recruiting)
- Inova Fairfax Hospital — Falls Church, Virginia, United States (Not_yet_recruiting)
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Terminated)
- UZ Leuven - Campus Gasthuisberg — Leuven, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Amy A Lautenbach, MAOL
- Email: amy.a.lautenbach@medtronic.com
- Phone: (763)360-9163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.