To investigate whether high resolution multi-site epicardial mapping of the atria in patients with structural heart disease undergoing cardiac surgery can identify patients at risk for developing early post-operative atrial fibrillation. The…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is reached when atrial fibrillation develops.
There is a follow-up period of 5 years after cardiac surgery. Each year, the
participant will be called by the investigator in order to check whether atrial
fibrillation has occurred.
Secondary outcome
NA
Background summary
Rationale: Post-operative AF after cardiac surgery affects not only early but
also late mortality. The exact mechanism of post-operative AF is still unknown.
Subsequently, at present there are no diagnostic tools available to identify
patients at risk pre-operatively.
Objective: To investigate whether high resolution multi-site epicardial mapping
of the atria in patients with structural heart disease undergoing cardiac
surgery can identify patients at risk for developing early post-operative
atrial fibrillation.
Study objective
To investigate whether high resolution multi-site epicardial mapping of the
atria in patients with structural heart disease undergoing cardiac surgery can
identify patients at risk for developing early post-operative atrial
fibrillation. The acquired knowledge will be used in clinical practice to
ensure an appropriate selection of patients for AF therapy and to improve
existing AF treatment modalities
Study design
This study is designed as an observational study. Patients will be recruited at
the department of thoracic surgery. The investigator is responsible for patient
selection and appropriate inclusion. Patients scheduled for routine cardiac
surgery will be asked to participate in this study.
Intervention
Epicardial mapping during CABG
Study burden and risks
Max. extension of 10-15 minutes of the surgical procedure
Max. 15 minutes per Follow-Up visit (Outpatient Clinic) once per year and a
total Follow-up of 5 years.
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
's Gravendijkwal 230
ROTTERDAM 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients > 18 years scheduled for standard cardiac surgery.
Exclusion criteria
paced atrial rhythms
usage of anti-arrhythmic drugs
hemodynamic instability
presence of assist devices
usage of inotropic agents
emergency cardiac surgery
redo-cardiac surgery
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 | NL31162.078.10 |