to compare the efficacy and safety of complex fractionated atrial electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation based ablation in patients with persistent atrial fibrillation (AF).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Freedom from recorded atrial fibrillation or atrial flutter or atrial
tachycardia recurrences (>30 seconds) without the use of AADs through 18 months
follow-up, post-blanking, on either a 12 lead ECG on visits or on 24 hour
holter monitoring or on symptom-driven event monitoring.
Secondary outcome
• Freedom from recorded atrial fibrillation or atrial flutter or atrial
tachycardia recurrences (>30 seconds) through 18 months follow-up on
either a 12 lead ECG on visits or on 24 hour holter monitoring or on
symptom-driven event monitoring, regardless of antiarrhythmic drugs
• Freedom from recorded atrial fibrillation or atrial flutter recurrences (>30
seconds) through 18 months follow-up on either a 12 lead ECG on
visits or on 24 hour holter monitoring or on symptom-driven event
monitoring, regardless of antiarrhythmic drugs
• Freedom from recorded atrial fibrillation or atrial flutter or atrial
tachycardia recurrences (>30 seconds) through 18 months follow-up on
either a 12 lead ECG on visits or on 24 hour holter monitoring or on
symptom-driven event monitoring, without a new AAD or a previously
failed AAD at a greater than the highest ineffective historical dose
• Freedom from recorded atrial fibrillation (>30 seconds) through 18 months
follow-up on either a 12 lead ECG on visits or on 24 hour holter
monitoring or on symptom-driven event monitoring, regardless of
antiarrhythmic drugs
• Clinical/partial success at 18 months regardless of antiarrhythmic drug use,
defined as a 75% or greater reduction in the number of AF
episodes and/or the duration of AF episodes, or the % time a patient
is in AF as assessed with a device capable of measuring AF burden.
• Time to first symptomatic, recorded AF recurrence
• Time to first electrocardioversion
• Symptoms associated with atrial arrhythmias
• Decreased anti-arrhythmic and/or anticoagulant drug requirements
• Quality of life at 6 and 12 months compared to baseline
• Number of redo-procedures
• Total time of fluoroscopy
• Total procedure time (minutes from introduction of first catheter to
withdrawal of last catheter)
• Total ablation time
Background summary
Pulmonary vein isolation (PVI) is a class I indication for drug refractory,
symptomatic, paroxysmal atrial fibrillation.2 PVI however, is considered to be
not enough for treatment of persistent AF.1,3 To improve the clinical outcome
in patients with persistent AF, extensive ablation, including wide antral
pulmonary vein isolation and/or multiple linear lesions and/or ablation of
complex fractionated atrial electrograms (CFAEs) has been adopted.2-12 Various
randomized trials used CFAEs as an additional after PVI, but the results of
Nademanee (87% of patients in sinus rhythm after 2.3 years) could not be
reproduced.13-16 Nevertheless, in these studies and in a meta-analysis CFAE
ablation on top of PVI did improve atrial fibrillation free survival in
persistent atrial fibrillation patients (47% to 62%).13-17 As in the study of
Nademanee, another study using primarily a CFAE ablation strategy, not on top
of pulmonary vein isolation, reported a 82% atrial fibrillation free
survival.18 However, in persistent atrial fibrillation, a strategy using CFAE
ablation until AF termination during ablation, as primary ablation was never
compared to a PVI based strategy.
Study objective
to compare the efficacy and safety of complex fractionated atrial
electrocardiograms (CFAEs) guided ablation to pulmonary vein isolation based
ablation in patients with persistent atrial fibrillation (AF).
Study design
A prospective, multicenter, randomized unblinded clinical study
Eligible patients who sign the study informed consent form will be randomized
into one of two study arms:
• CFAE guided ablation: CFAE mapping and ablation during AF aimed at restoring
sinus rhythm during ablation, according to methods by
Nademanee9. PVI will be checked before and after ablation using a
mapping catheter
• PVI guided ablation: wide antral pulmonary vein isolation during mapping
catheter control of pulmonary vein signals
Intervention
CFAE guided ablation
PVI guided ablation
Study burden and risks
Participating patients will not have extra risks
The extra load for the patient will be to fill the quality of live questionares
during the study
It is not expected that the patients will have any benifit by participating in
the trial
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
1. Patients with persistent atrial fibrillation, defined as atrial fibrillation
which is:
a. Sustained beyond 7 days but no more than one year
b. Or lasting less than 7 days, but longer than 48 hours and necessitating
pharmacologic or electrical cardioversion
2. Documentation of atrial fibrillation on either a 12-lead ECG or
transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry
strip and a physician*s note showing continuous AF.
3. Failure of at least one antiarrhythmic drug (AAD) (Class I or III) as
evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
Exclusion criteria
1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
1. Previous surgical or catheter ablation for atrial fibrillation
2. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
3. CABG surgery within the past 6 months (180 days)
4. Subjects that have ever undergone valvular cardiac surgical procedure
5. Cardioversion refractory (the inability to restore sinus rhythm for 30 secs
or longer following electrical cardioversion).
6. Documented LA thrombus on imaging
7. LA size >50 mm
8. LVEF < 30%
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 | NL54589.075.15 |