Evaluating management of patients with implanted cardiac devices during surgery
Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinikum-Fuerth Academic / other |
| Locations | 2 sites (Fürth, Bavaria and 1 other locations) |
| Trial ID | NCT04331249 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients without an implanted CIED or those lacking peri-interventional CIED interrogation data may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Fürth, Bavaria and 1 other locations
- 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
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.