To establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery. Secondary objectives are comparison of the duration and hospitalization costs.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients without a recurrence of AF, without AADs, within a
follow-up period of at least 12 months after a stabilisation period of 90 days
after the initial procedure. An episode of AF is defined as an episode of at
least 30 seconds duration.
The percentage of patients without post-operative atrial fibrillation during
admission. An episode of AF is defined as an episode of at least 30 seconds
duration.
Secondary outcome
Secondary outcomes include comparison of cost and duration of hospitalization,
post-procedural discomfort and experienced AF burden during follow-up.
Background summary
Recent studies demonstrated that radiofrequency isolation of the pulmonary
veins (PVI) is a superior alternative to antiarrhythmic drug therapy in
patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial
proportion of patients undergoing elective cardiac surgery also suffer from
atrial fibrillation. No evidence exists if epicardial PVI is beneficial in
patients with a history of AF undergoing coronary bypass surgery (CABG) for the
concomitant treatment of AF.
Study objective
To establish the effectiveness of incorporating epicardial pulmonary vein
isolation into elective cardiac surgery. Secondary objectives are comparison of
the duration and hospitalization costs.
Study design
Concomitant epicardial PVI in patients with atrial fibrillation undergoing
elective cardiac surgery is a prospective single center study.
Intervention
Concomitant epicardial pulmonary vein isolation versus *usual care* based on a
1:1 randomization strategy.
Study burden and risks
Using a strategy combining elective surgery with an extra intervention will
introduce almost no extra discomfort or procedural risks. The application of a
proven treatment of pulmonary vein isolation will most likely result into
reduction of atrial fibrillation burden. Based on consensus statement regarding
AF research, patients will undergo a seven day eventrecorder registration
during follow-up adding some burden to study participation.
Haaksbergerstraat 55
7513 ER
NL
Haaksbergerstraat 55
7513 ER
NL
Listed location countries
Age
Inclusion criteria
Patients >= 18 years of age
EHRA class <= 2
Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
Patients will have elective coronary surgery planned
Able of providing informed consent
Exclusion criteria
Patients >=70 years of age
Pregnancy
Patients with contraindications for oral anticoagulant agents.
Patients undergoing emergency operation
Patients undergoing concomitant valve replacement
Severely enlarged LA (>50 mm) on echocardiography
Prior AF ablation or AF surgery
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 | NL35192.044.11 |