To investigate the real incidence of POAF a Reveal device is implanted. Afterwards a risk stratification of POAF is made.Using modern mapping equipment and techniques, it is now possible to investigate the substrate for development of atrial…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of POAF untill 3 months after cardiac surgery.
determining an electrophysiological substrate for development of post operative
atrial fibrillation.
Secondary outcome
Incidence of POAF untill 3years after cardiac surgery.
Determine risk factors for early and late POAF.
Detect pre-operative (unnoticed) episodes of AF.
Determining an electrophysiological and histological substrate for the
incidence of paroxysmal AF in the first 3 years post cardiac surgery.
Background summary
Postoperative atrial fibrillation (POAF) after cardiac surgery is a common (1
in 3) complication and associated with morbidity and mortality. Not all
episodes of AF are noticed and detected, especially after discharge.
There is evidence suggesting there is an electrophysiological and histological
atrial substrate making patients susceptible for development of postoperative
atrial fibrillation but also paroxysmal AF. This however has not yet been
thoroughly investigated.
Study objective
To investigate the real incidence of POAF a Reveal device is implanted.
Afterwards a risk stratification of POAF is made.
Using modern mapping equipment and techniques, it is now possible to
investigate the substrate for development of atrial fibrillation. This
potentially has great consequences for prevention and treatment of this highly
morbid arrhythmia.
Study design
130 patients will receive a Reveal device. Data will be substracted from the
device at different moments from home.
Mapping during the operating will take place in 100 patients in AZM.
Study burden and risks
There is a small risk of minor complications (hemorrhage and infection of the
pocket).The device can be explanted easyly if necessary. Ther is a burden of
the im- and explantation of the device (local anesthesia, approx. 20 minutes).
Patient will have to visit the out-hospital clinic twice.
The operation can be prolonged with 30 minutes for the purpose of mapping.
Untill now there are no specific risks known to be associated with this
procedure.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Undergoing elective cardiac surgery.
Exclusion criteria
AF in history.
Pacemaker.
Cardiac surgery before.
Participation in other study.
Patient not willing to co-operate.
Design
Recruitment
Medical products/devices used
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 | NL37204.060.11 |