NCT04331249 Perioperative Management Evaluation in Patients With CIED
| NCT ID | NCT04331249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klinikum-Fuerth |
| Condition | Cardiac Pacemaker Malfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-11-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2018-11-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Dirk Bastian, MD
PRINCIPAL INVESTIGATOR
Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society
Frequently Asked Questions
Who can join the NCT04331249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Pacemaker Malfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04331249 currently recruiting?
Yes, NCT04331249 is actively recruiting participants. Contact the research team at dirk.bastian@klinikum-fuerth.de for enrollment information.
Where is the NCT04331249 trial being conducted?
This trial is being conducted at Fürth, Germany, Nuremberg, Germany.
Who is sponsoring the NCT04331249 clinical trial?
NCT04331249 is sponsored by Klinikum-Fuerth. The principal investigator is Dirk Bastian, MD at Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society. The trial plans to enroll 500 participants.