Actively Recruiting
Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
Led by Klinikum-Fuerth · Updated on 2024-10-15
500
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
K
Klinikum-Fuerth
Lead Sponsor
K
Klinikum Nürnberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the management and outcomes of patients with implanted cardiac electronic devices (CIED) who undergo surgeries or catheter-based procedures unrelated to their device. This observational study collects both past and ongoing patient data to understand peri-operative device-related events better and improve care recommendations. The study is conducted at two centers and includes a broad range of patient characteristics and procedure types. The study involves patients with implanted CIEDs such as pacemakers, ICDs, or CRT devices undergoing non-CIED related surgeries or catheter interventions like radiofrequency ablation. Data are gathered retrospectively from records starting in 2008 and prospectively from ongoing patients. The focus is on documenting adverse device events related to procedures and any changes observed in device function before and after interventions. Participants provide data through routine clinical records, device interrogations, and procedural information. Researchers monitor adverse events related to devices during and after procedures, including device reprogramming or revisions needed. Outcomes like pacing threshold, sensing, and lead impedance are assessed at one month post-procedure. Data security is maintained with anonymized, password-protected records, and the study adds no additional risk to participants.
CONDITIONS
Brief Title
Perioperative Management Evaluation in Patients With CIED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Implanted cardiac electronic device such as pacemaker, ICD, or CRT
- Undergoing a surgical or catheter-based procedure not related to the cardiac device
- Data from device interrogation around the time of the procedure is available
- Age over 18 years
You will not qualify if you...
- No implanted cardiac electronic device
- No available data from device interrogation during the peri-procedural period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies per procedure
Participants with implanted cardiac electronic devices undergo non-device related surgery or catheter-based cardiac procedures such as catheter ablation.
1 procedural visit (in-person)
Duration - 1 month post-procedure
Participants are monitored for device function and any adverse device-related events up to 1 month after the procedure.
Visits for device interrogation and assessment during the month following procedure
Trial Site Locations
Total: 2 locations
1
Klinikum Fuerth
Fürth, Bavaria, Germany, 90766
Actively Recruiting
2
Klinikum Nuernberg
Nuremberg, Bavaria, Germany, 90471
Actively Recruiting
Research Team
D
Dirk Bastian, MD
L
Laura Vitali-Serdoz, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here