Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04331249 |
| Other study ID # |
EVINCE_KHF |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 27, 2018 |
| Est. completion date |
December 2030 |
Study information
| Verified date |
June 2023 |
| Source |
Klinikum-Fuerth |
| Contact |
Dirk Bastian, MD |
| Phone |
+49 (0)911 7580 1101 |
| Email |
dirk.bastian[@]klinikum-fuerth.de |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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
