To determine the add-on value of bi-atrial pacing in combination with standardised Sotalol treatment for the prevention of postoperative atrial fibrillation (POAF).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the difference in incidence, frequency and duration of POAF after
cardiac surgery.
To study the development of the electropathological atrial substrate.
Secondary outcome
Clinical characteristics (age, echographic measurements, AF history, mediacion,
'AF burden', etc)
Histological and biochemical study of tissue (degree of fibrosis, hypertrophy,
etc).
Study of biomarkers in blood.
Background summary
Postoperative atrial fibrillation (POAF) is an important complication of
cardiothoracic surgery. Pharmacological strategies can diminish, but not
prevent POAF, therefore other than pharmacological treatments need to be
developed in order to reduce the incidence of POAF.
Atrial fibrillation (AF) is the most frequent cardiac arrhythmia in adults with
growing socio-economic burden. Although a significant progress has been made in
understanding the pathophysiology of this arrhythmia, treatment of AF patients
is still far from satisfactory. The success rate of electric cardioversion is
still limited and anti-arrhythmic drugs are unable to prevent recurrences of
AF. Prevention of thromboembolic events still requires anticoagulation therapy
with all the associated risks. Ablation techniques vary in their efficacy to
cure persistent AF. Only a better understanding of this disease can lead to a
better treatment.
Study objective
To determine the add-on value of bi-atrial pacing in combination with
standardised Sotalol treatment for the prevention of postoperative atrial
fibrillation (POAF).
Study design
: This is an open prospective randomised trial, comparing two treatment
strategies (with or without bi-atrial pacing) for postoperative AF on a
long-term basis, using trans-telephonic electrocardiographic monitoring until 6
weeks after surgery. Epicardial mapping will be conducted in patients in the
non-pacing group and in patients with concomitant AF.
Intervention
Bi-atrial pacing for 72 hours postoperatively.
Study burden and risks
Their will be no risk of thromboembolic event during induction of acute AF as
the patients will be heparinised. Mapping will take place before
cardiopulmonary bypass and will not affect the aortic clamp time. There will be
a 6 weeks postoperative follow-up.
Universiteitssingel 50 25
Maastricht 6229 ER
NL
Universiteitssingel 50 25
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Patients with and without preoperative AF history who undergo isolated CABG or valve surgery.
Patients have given written consent.
Exclusion criteria
Patients who are scheduled for reoperation
Patients who do not speak/understand Dutch
Patients with sick sinus syndrome, AV-block or internal pacemaker
Patients who are not will-competent
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 | NL21417.068.08 |