The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to evaluate which ablation strategy- PVAI
alone or PVAI plus limited ablation of CFAE*s in a specific region of the left
atrium- is most effective in treating persistent and longstanding persistent
atrial fibrillation measured by success at 12 months after 1 or 2 procedures.
Success is defined as freedom from recurrences following the 3-month blanking
period in the absence of Class I and III AAD therapy.
Recurrence is defined as recurrence of atrial fibrillation, atrial flutter or
atrial tachycardia of at least 30 seconds* duration that is documented by an
ECG or device recording system more than 3 months following AF-ablation.
Secondary outcome
-procedural duration
-fluoroscopy time
-number of repeat procedures
-number of patients showing CFAE in the particular region of the left atrium
-incidence of periprocedural complications
-quality of life measurements before and after ablation
Background summary
Atrial fibrillation (AF) is the world*s most common cardiac arrhythmia. It is
responsible for a significant morbidity and mortality in the general population
primarily caused by congestive heart failure and ischemic stroke. Catheter
ablation is a well-established treatment option in patients with
symptomatically, drug refractory atrial fibrillation. During the past decade it
transformed from a experimental approach to a commonly worldwide performed
procedure. The cornerstone of catheter ablation is pulmonary vein antrum
isolation (PVAI). Over the last years catheter ablation is being applied
increasingly in patients with persistent and longstanding persistent AF. In
these patients the outcome of PVAI is more disappointing than in patients with
paroxysmal AF.
Different ablation strategies have developed over the years, with special focus
on the ablation of complex fractionated atrial electrograms (CFAE) and
additional linear ablation lesions. CFAE*s are very rapid electrograms or
electrograms with multiple, continuous split components. They may represent
areas in the atrium that contribute to re-entry and maintain AF. On the other
hand they also may indicate sites of non-pulmonary vein triggers for AF.
Incomplete linear lesions and irregular ablation lesions after (extensive)
ablation of CFAE's may act pro-arrhythmic and lead to (macro) re-entry
tachycardia*s.
To this day, the optimal primary approach for catheter ablation of
(longstanding) persistent AF remains unclear. Recently, our focus shifted to
fractionated electrograms in the area under the right inferior pulmonary vein,
the inferior left atrial septum and the ostium and roof of the coronary sinus.
Several patients who underwent a repeat procedure, showed CFAE in these
particular regions of the left atrium. Ablation of these CFAE led to good
results (unpublished data)
Study objective
The aim of this study is to determine if adding ablation restricted to
specific areas of the left atrium to PVAI is superior to the standard care PVAI
alone.
Study design
A single center, randomized controlled single-blind intervention study
Intervention
pulmonary vein antrum isolation plus limited ablation of CFAE*s in a specific
region of the left atrium (the area under the right inferior pulmonary vein,
the inferior left atrial septum and the ostium and roof of the coronary sinus)
Study burden and risks
A recent systematic review concluded that ablations of CFAE showed no
significant difference in complication rate compared with PVAI.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Patients age is >= 18 years
- Patients with persistent or longstanding persistent atrial fibrillation.
- Patients undergoing a first time ablation procedure for persistent atrial fibrillation
- AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device.
- Patients must give informed consent to participate
Exclusion criteria
- Patients suffering from paroxysmal atrial fibrillation.
- Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the left atrium, such as pregnancy or presence of a left atrial thrombus
- Prior PVAI with RF or cry ablation
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 | NL48677.041.14 |