perioperative atrial fibrillation
Conditions
Interventions
Group 1: Patients undergoing elective or urgent non-cardiac surgery will be examined as part of the study with regard to the occurrence of perioperative atrial fibrillation (periAF). The primary objec
Sponsors
Klinik und Poliklinik für Kardiologie
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients undergoing surgery in the following specialist departments: thoracic surgery, general and visceral surgery, vascular surgery, orthopedics, and urology. • Inclusion no more than 28 days and at least 18 hours before surgery. • Age = 55 years. • Signed informed consent form available.
Exclusion criteria
Exclusion criteria: The exclusion criteria are defined as follows: • Pre-existing atrial fibrillation • Emergency surgical procedures • Patients incapable of giving consent • Patients who are hospitalized by court order or official order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PeriAF, which occurs intraoperatively and within 30 days after surgery. PeriAF is defined as clinically relevant, newly occurring intraoperative or postoperative atrial fibrillation that occurs within 30 days after surgery. Rhythm monitoring is performed intraoperatively using a Holter-ECG. This is followed by intensive postoperative rhythm monitoring for the first 72 hours after surgery, the phase with the highest probability of periAF occurrence, using Holter-ECG. PeriAF events occurring after these 72 hours and up to the 30th postoperative day are also considered a primary endpoint if reliable source data (12-lead ECG, rhythm strip, and/or documentation using wearables) is available for these events (see below). For the purposes of the study, clinically relevant periAF is defined as meeting at least one of the following criteria: o AF documented in the intraoperative Holter-ECG and lasting = 30 seconds. o AF documented in the postoperative 72-hour ECG and lasting = 30 seconds. o AF documented within 72 hours to 30 days postoperatively by means of a 12-lead ECG measurement. o AF documented within 72 hours to 30 days postoperatively in the rhythm strip, by means of an event recorder or wearable device, and lasting = 30 seconds. o AF within 72 hours to 30 days postoperatively in telemetric monitoring, which is accompanied by symptoms such as angina pectoris, heart failure, or hypotension and/or requires frequency or rhythm control and is documented in accordance with the specifications below. This applies, for example, if patients are monitored telemetrically beyond the first 72 hours after surgery (e.g., due to an extended stay in an intensive care unit/ICU or intermediate care unit/IMC) and/or patients who have undergone follow-up surgery. Reliable source data for the detection of periAF is defined as follows: 12-lead ECG, rhythm strip, extracted file from an event recorder, extracted file from a wearable device. Episodes of periAF that occur du | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of the following late complications up to the end of the study will be evaluated as a secondary endpoint: o Manifest atrial fibrillation (AF): Manifest AF is defined as AF occurring outside the defined perioperative period and diagnosed by a physician. o Ischemic strokes o Myocardial infarctions o Unplanned hospitalizations o Deaths | — |
Countries
Germany
Contacts
Public ContactElisabeth Richter
Klinik und Poliklinik für Kardiologie
Outcome results
None listed