Perioperative Management Evaluation in Patients With CIED

NCT ID: NCT04331249

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2030-12-31

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.

Detailed Description

Background: The number of worldwide implanted cardiac electronic devices (CIED) is increasing continuously. On the other hand, the number of (more and more complex) surgical and catheter based interventions in this population is increasing as well. Recommendations for peri-operative management are often based on older data from case reports and small collectives. Data especially in particular subpopulations is limited.

Objective: The study aims to evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter interventional procedures (ablation) in clinical routine. Data from the study are expected to provide evidence for recommendations improving perioperative management and device programming.

Study design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics Centers: Klinikum Fuerth (dep. for Heart and Lung disease, section for clinical electrophysiology), Klinikum Nuernberg (dep. for Heart surgery).

Patients and methods:

Primary endpoint: number and type of peri-operative adverse device related events (ADE)

• all complaints, adverse events and adverse device effects will be documented and classified according to the ISO/DIS 14155 - Clinical Investigation of medical Devices in Human Subjects - Good Clinical Practices with respect to their relationship to the surgical or catheter intervention and [Stark NJ. A New standard for medical device adverse event classification. J of Clinical Research Best Practices 2009; 5(12): 1-7].

Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery/intervention, anesthesiology techniques, any AE), post-interventional data (data from post-interventional CIED interrogation, need for reprogramming / device revision).

Subpopulations: cardiac surgery, vascular surgery, catheter ablation, ICD and mode of therapy inhibition, CRT, automatic features

Inclusion criteria:

patients with implanted CIED undergoing non-CIED related surgical or catheter-based procedure, peri-procedural CIED interrogation, age >18 years Exclusion criteria: no implanted CIED, no data from peri-procedural CIED interrogation available.

Patient enrollment: retrospectively from the clinical records beginning from 2008, further on-going prospective inclusion Data acquisition: Data will be collected in CRF´s from the patient's history, the computer based clinical information system / clinical records and data records from CIED interrogations

Sample size: For the observational study, there is no pre-specified sample size.

Data from more than 500 patients undergoing > 700 interventions are expected.

Data security: Study related data are collected by the study investigators in an anonymous clinic-internal data-base, that is password protected.

All investigators have to provide valid GCP training.

Risk estimation: the study is observational and descriptive with anonymized data collection/analysis and therefore adds no risk to the study population

Conditions

Cardiac Pacemaker Malfunction; ICD Malfunction; Cardiac Pacemaker Electrical Interference; Anesthesia Complication; Surgery--Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

surgery or catheter based cardiac procedure (catheter ablation)

patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Nürnberg

OTHER

Sponsor Role: collaborator

Klinikum-Fuerth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Bastian, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Fuerth, European Society of Cardiology, European Heart Rhythm Society

Locations

Klinikum Fuerth

Fürth, Bavaria, Germany

Site Status: RECRUITING

Klinikum Nuernberg

Nuremberg, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dirk Bastian, MD

Role: CONTACT

dirk.bastian@klinikum-fuerth.de

+49 (0)911 7580 1101

Laura Vitali-Serdoz, MD

Role: CONTACT

laura.vitali-serdoz@klinikum-fuerth.de

+49 (0)911 7580 1101

Facility Contacts

Dirk Bastian, MD

Role: primary

dirk.bastian@klinikum-fuerth.de

+49 (0)911 7580 1101

Laura Vitali-Serdoz, MD

Role: backup

laura.vitali-serdoz@klinikum-fuerth.de

+49 (0)911 7580 1101

Timur Mamedov

Role: primary

timur.mamedov@klinikum-nuernberg.de

Other Identifiers

EVINCE_KHF

Identifier Type: -

Identifier Source: org_study_id