management of post-operative patients perioperative diagnosis of arrhythmias
Conditions
Interventions
Participation in the PRISM2 study will require patients to undergo the
following additional clinical procedures:
Implantation of Reveal XT
Holtermonitoring for 72 hrs during and after vascular surger
Sponsors
Medtronic Bakken Research Center B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is scheduled for non-cardiac vascular surgery of the for elective aortic abdominal aneurysm repair or lower extremity bypass surgery; Patients eligible for the study are 18 years or older; Patient is willing to receive a Reveal XT insertion and can be implanted with Reveal XT; Patient is willing to wear external Holter devices for a 72 hour period; Patient is willing to give his/her informed consent;
Exclusion criteria
Exclusion criteria: Patient has an implanted pacemaker or ICD; Patient has an allergy against adhesive surface ECG electrode; The study will interfere with a therapeutic or diagnostic procedure which is planned or expected within the study period; Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study. Patients has electrocardiographic abnormalities that preclude assessment of cardiac arrhythmias or myocardial ischemia will be excluded. Patient has a changing ST-segment, i.e. a Bundle Branch Block and further ST-segment changes cannot be assessed. Patient is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The detection of arrhythmic episodes by Reveal XT will be compared to the standard 12-lead surface ECG. | — |
Countries
Netherlands
Outcome results
None listed