Evaluating management of patients with implanted cardiac devices during surgery
Official title: Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
Run by Klinikum-Fuerth · NCT04331249 · Data updated 2026-11-12
This study looks at how to better manage patients with heart devices during surgeries that aren't related to those devices to help improve their safety and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Klinikum-Fuerth Academic / other |
| Locations | 2 sites (Fürth, Bavaria and 1 other locations) |
| Status | Recruiting |
| Started | November 27, 2018 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2030 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT04331249 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years with an implanted CIED who are scheduled for non-CIED related surgical or catheter-based procedures.
✕Probably not a fit
Patients without an implanted CIED or those lacking peri-interventional CIED interrogation data may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the peri-operative management and outcomes of patients with implanted cardiac electronic devices (CIED) who are undergoing non-CIED related surgeries or catheter interventions. It involves a bi-center approach with retrospective data collection and ongoing prospective enrollment at Klinikum Fuerth and Klinikum Nuernberg. The primary focus is on documenting and classifying peri-operative adverse device-related events, along with gathering comprehensive pre-, peri-, and post-interventional data to improve future management recommendations.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of surgical procedures for patients with implanted cardiac devices.
How similar studies have gone: While there is limited data on this specific approach, previous studies have indicated the need for updated recommendations in managing patients with CIED during surgical procedures.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * implanted CIED (e.g. pacemaker, ICD, CRT), * performed (non-CIED related) surgical or catheter-based procedure, * data from peri-procedural CIED interrogation available * age \>18 years Exclusion Criteria: * no implanted CIED, * no data from any peri-interventional CIED interrogation available
Where it's running
-
Klinikum Fuerth
Fürth, Bavaria, Germany Recruiting -
Klinikum Nuernberg
Nuremberg, Bavaria, Germany Recruiting
Study contacts
- Principal investigator: Dirk Bastian, MD — Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society
- Study coordinator: Dirk Bastian, MD
- Email: dirk.bastian@klinikum-fuerth.de
- Phone: +49 (0)911 7580 1101
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.