to demonstrate persistent atrial fibrillation is associated with endocardial and epicardial dissociation of the heart.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
parameter obtained from the mapping procedure: percentage of discontinuous
conduction.
Secondary outcome
Differences between the endo- and epicardium in electrophysiological parameters.
Development of (persistent) atrial fibrillation during the 5-year follow-up
period is an endpoint
Background summary
Atrial fibrillation (AF) is a common arrhythmia en incidence is expected to
further increase over the next years. AF is associated with an increased risk
of cerbrovascular accidents (CVA) and transient ischemic attacks (TIA).
Consequently, the number of hospital admissions due to AF will also increase.
Therapies often are unsuccesfull or give temporary results and are even less
succesfull if patients have persisent forms of AF.
The cause for development or progression of AF is still unclear. In the past,
studies have shown that dissociation and conduction delay occurs between
following atrial cells during atrial fibrillation. More recently studies have
also demonstrated in an atrial model of the goat that dissociation occurs
between endo- and epicardial layers of the atrium during persistent AF. Our
hypotheses is that also in humans with persistent AF dissociation occurs
between de endo-and epicardial layers of the heart.
Study objective
to demonstrate persistent atrial fibrillation is associated with endocardial
and epicardial dissociation of the heart.
Study design
This is an interventional study. During cardiac surgery endo-epicardial mapping
will be performed during sinus rhythm and atrial fibrillation and biopsy of the
heart appendage is performed. The only intervention exist of inducement of
atrial fibrillation, if neccessary, via pacing with standard pacemaker leads.
This is frequently done in other (i.e. elektrophysiological) procedures. There
is a follow-up period of five years, which consists of two visits to our
out-patient clinic with collection of a blood sample and four telephone calls.
Intervention
Pacing: Atrial Fibrillation will be induced by a standard pacemaker during the
procedure
Study burden and risks
Extension of max. 15 minutes of the surgical procedure and 6 telephone calls
within 5 years. On admission an extra blood sample will be taken (if possible)
during routine blood sampling. Pacing and Epicardial mapping has been performed
extensively in the Erasmus MC (QUASAR, MEC 2010-054) without any complications
related to the electrode so far. Possible complications are those similar to
standard complications of the cardiothoracic surgical procedure.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
patients > 18 years scheduled for standard cardiac surgery
Exclusion criteria
emergency cardiac surgery
prior left-sided radiation of the chest for malignancies
Severe kidney or liver failure
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL50711.078.15 |
| OMON | NL-OMON26625 |