Actively Recruiting
Perioperative Management Evaluation in Patients With CIED
Led by Klinikum-Fuerth · Updated on 2024-10-15
500
Participants Needed
2
Research Sites
631 weeks
Total Duration
On this page
Sponsors
K
Klinikum-Fuerth
Lead Sponsor
K
Klinikum Nürnberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives. Objective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine. Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Primary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision). Inclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available Patient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \> 700 interventions are expected.
CONDITIONS
Official Title
Perioperative Management Evaluation in Patients With CIED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Implanted cardiac electronic device (e.g., pacemaker, ICD, CRT)
- Undergoing a non-CIED related surgical or catheter-based procedure
- Data from peri-procedural CIED interrogation available
- Age over 18 years
You will not qualify if you...
- No implanted cardiac electronic device
- No data from any peri-interventional CIED interrogation available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Laura Vitali-Serdoz, MD
CONTACT
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
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