Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Klinikum Fuerth
RECRUITING
Fürth
Klinikum Nuernberg
RECRUITING
Nuremberg
Contact Information
Primary
Dirk Bastian, MD
dirk.bastian@klinikum-fuerth.de
+49 (0)911 7580 1101
Backup
Laura Vitali-Serdoz, MD
laura.vitali-serdoz@klinikum-fuerth.de
+49 (0)911 7580 1101
Time Frame
Start Date: 2018-11-27
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 500
Related Therapeutic Areas
Sponsors
Leads: Klinikum-Fuerth
Collaborators: Klinikum Nürnberg

This content was sourced from clinicaltrials.gov