Actively Recruiting
Evaluation of Perioperative Care and Outcomes in Adults with Implanted Cardiac Electronic Devices Undergoing Non-Device Surgeries or Catheter Procedures
Led by Klinikum-Fuerth · Updated on 2024-10-15
500
Participants Needed
2
Research Sites
260 weeks
Total Duration
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
Research Team
D
Dirk Bastian, MD
L
Laura Vitali-Serdoz, MD
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