1. To capture (true) arrhythmic episodes in patients after a major vascular surgery procedure.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The detection of arrhythmic episodes by Reveal XT will be compared to the
standard 12-lead surface ECG.
Secondary outcome
not applicable
Background summary
The Reveal XT insertable cardiac monitor is indicated for patients at increased
risk of cardiac arrhythmias, and for patients that experience transient
symptoms indicative of cardiac arrhythmias.
Currently, patients scheduled for major vascular surgery are being assessed for
clinical predictors of increased cardiovascular risk, including unstable
coronary syndromes, decompensated heart failure, significant arrhythmias, and
valvular disease. In the ACC/AHA 2007 Guidelines on Peri-operative
Cardiovascular Evaluation and Care for Noncardiac Surgery the clinical practice
concerning the identification and management of patients with post-operative
arrhythmias and conducting disorders is being addressed.
According to these guidelines patients should be actively monitored
post-operatively for cardiac arrhythmia*s (until discharge from the hospital)
to allow physicians to manage their patients for example by prescribing
anti-arrhythmic agents.
Currently, patient monitoring in the peri-operative setting can be achieved by
Holter monitoring. However, this is being done in a discontinuous fashion and
is only possible for a limited amount of time.
The use of the Reveal XT for post-operative risk assessment could improve the
identification of patients at increased cardiovascular risk by increasing the
time window of monitoring for arrhythmia and ischemia.
Study objective
1. To capture (true) arrhythmic episodes in patients after a major vascular
surgery procedure.
Study design
The PRISM2 study is a research, non-randomized, open-label, single-center
study.
The study will be conducted at the department of Vascular Surgery, Erasmus
Medical Center, Rotterdam, The Netherlands.
Intervention
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 surgery
Explant of Reveal XT
The study duration will amount to 8 weeks with a possilbe extension of 2 weeks
Study burden and risks
The potential risks to a subject participating in this study are expected to be
similar to those encountered during standard Reveal XT implantation, use,
explantation, ECG testing and Holter recording.
Reveal XT implantation will lead to scar formation. Other related events
including pocket inflammation, and erosion through the skin have been
estimated to occur in less than 1% of the cases.
Endepolsdomein 5
6229 GW Maastricht
Nederland
Endepolsdomein 5
6229 GW Maastricht
Nederland
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22719.078.08 |