To assess if serial hybrid ablation for freedom of AF is superior to epicardial ablation alone in patients with (long-standing) persistent AF
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serial hybrid ablation for freedom of AF (AF episode lasting more than 5
minutes or overall burden >0.5% of time spent in AF on a monthly basis) after a
follow-up of 12 months is superior to epicardial ablation alone in patients
with (long-standing) persistent AF.
Secondary outcome
the number of pulmonary veins needing re-isolation by the EP during the
endocardial intervention. The percentage of cross-over from the surgical arm to
surgery and serial hybrid ablation, after patients have reached the primary
endpoint AF. The occurence of atrial ectopy (monomorphic and multiform atrial
extrasystoles) even during the blanking. Number of complications and
thrombo-embolic events in both groups. Necessity of antiarrhythmic drugs to
maintain sinus rhythm. Burden of AF in both groups if AF is still present.
Background summary
Treatment of (long-standing) persistent atrial fibrillation (AF) remains
cumbersome and the surgical (epicardial) approach seems to be the most
effective. Still, however a significant amount of failures exist which is
mostly due to incompleteness of the surgical ablation lines. Checking, and if
necessary additional ablation, of these lines afterwards endocardially by the
cardiologist (the so-called serial hybrid approach) could overcome this
problem.
Study objective
To assess if serial hybrid ablation for freedom of AF is superior to epicardial
ablation alone in patients with (long-standing) persistent AF
Study design
The study is designed as a prospective single centre randomized study, with a
follow-up of 1 year
Intervention
Patients will undergo a standardized surgical epicardial ablation for atrial
fibrillation and will subsequently be randomized for a second endocardial
intervention by the cardiologist/electrophysiologist (EP) after 6-8 weeks
versus regular follow-up.
Study burden and risks
If randomized to the serial hybrid arm patients will undergo a second procedure
performed by the EP. This is the regular procedure as also performed for
patients with (paroxysmal) atrial fibrillation and is done under complete
anesthesia. Risks for this procedure include the following (but not exclusive)
complications: 1) venous access related complications (hematoma, AV fistula):
1-3% 2) cardiac perforation with or without tamponade : <1% and 3)
thrombo-embolic events notably cerebro-vascular accidents: <1%. Patients need
to stay in the hospital for 1 night after the procedure and after discharge do
not have a recovery phase. Follow-up of these patients to assess successfulness
of the procedure consists of 5 outpatient visits which are one more than for
the regular procedure.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
All patients screened are accepted for pulmonary vein isolation according to the current guidelines.
1) candidates for enrolment should have long standing persistent or persistent AF as defined in the guidelines for which they received at least one cardioversion with EHRA class * II
2) Furthermore, on echocardiogram left atrial size needs to be more than >46 mm on long axis or >35 cc/m2.
Exclusion criteria
1) Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
2) Previous pulmonary vein isolation (epicardial or endocardial) or cardiac surgery. 3) Significant valvular disease present on echo (mitral or aortic valve regurgitation above grade 2, moderate to severe mitral or aortic stenosis). 4) Concomitant cardiac surgery needed 5) left ventricular ejection fraction <40% 6) hypertrophic (obstructive) cardiomyopathy or dilated cardiomyopathy defined as an ejection fraction < 40% 7) active infection or sepsis 8) pregnancy 9) myocardial infarction within the previous 3 months 10) AF secondary to electrolyte imbalance, thyroid disease, other reversible or noncardiovascular causes for AF 11) known sensitivity to heparin or warfarin 12) life expectancy of <12 months 13) pleural adhesions 14) prior thoracotomy 15) patients on dialysis
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 |
|---|---|
| ClinicalTrials.gov | NCT01582828 |
| CCMO | NL42236.044.12 |