Actively Recruiting

Age: 18Years +
All Genders
ID04331249

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery or Catheter-based Procedure

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)

Post-procedural Monitoring

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

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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

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