The aim of this study is to determine which treatment, SA or CA, is superior as a primary treatment option in patients suffering from symptomatic, drug refractory (longstanding) persistent AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Success after 1 procedure with a follow-up duration of 12 months.
Success is defined as: freedom of atrial fibrillation/atrial flutter/atrial
tachycardia >30 seconds following the 3 months blanking period in the absence
of Class I and III AAD therapy.
Secondary outcome
-The incidence of periprocedural complications.
-Clinical success (75% or greater reduction in the number of AF episodes, the
duration of AF episodes, or the % time a patient is in AF in the presence or
absence of previously ineffective AAD therapy) after the first procedure.
-Procedural duration.
-Success and clinical success after 2 procedures with a follow-up duration of
12 months. A second procedure will be performed through catheter ablation in
both groups.
-Quality of life measurements before and 6 months after the first procedure.
Background summary
Atrial fibrillation (AF) is the world*s most common cardiac arrhythmia. It is
responsible for significant morbidity and mortality in the general population
mainly caused by congestive heart failure and ischemic stroke. It may also lead
to an impaired quality of life with the requirement for chronic use of
medication. In case of symptomatic AF, refractory or intolerant to
antiarrhythmic medication, ablation treatment may be performed. There are two
treatment options using radiofrequency (RF) ablation, a transvenous approach
(catheter ablation) and a surgical approach.
Catheter ablation (CA) is a well-established treatment option in patients with
symptomatic, drug refractory atrial fibrillation. CA has proven to be a
curative treatment option in patients suffering from paroxysmal atrial
fibrillation. In patients with persistent and longstanding persistent AF the
outcomes of catheter abaltion are less satisfactory.
Surgical ablation (SA) is considered minimally invasive when performed through
Video Assisted Thoracoscopic Surgery (VATS). The results of minimally invasive
surgical ablation through VATS are promising.
No randomized controlled trial directly comparing CA and SA for the primary
treatment of (longstanding) persistent AF has been performed yet.
Study objective
The aim of this study is to determine which treatment, SA or CA, is superior as
a primary treatment option in patients suffering from symptomatic, drug
refractory (longstanding) persistent AF.
Study design
Single center randomised controlled intervention trial
Intervention
Minimally invasive surgical ablation through video assisted thoracoscopic
surgery
Study burden and risks
The first results of SA through VATS are promising. A systematic literature
overview and analysis of the first results and progress made SA showed 67%
success after one procedure in patients suffering from persistent AF after one
year. In studies applying the same additional left atrial linear lesions
success even increased to 79%.
Catheter ablation seems, especially after one procedure, less successful.
Experiences from the UMCU from 2009-2012 showed 38% success in patients with
persistent and longstanding persistent atrial fibrillation 1 year after the
primary ablation. This increased to 58% success one year after the second
procedure.
Hospitalization in the SA group is prolonged with 2-3 days compared with CA.
There*s conflicting evidence regarding the complication rates in SA compared
with CA. Two recent systematic reviews focussing separately on CA or SA,
concluded that the incidence of peri-procedural complications is approximately
6.3% for CA and 13.2% for SA, although the number of procedures studied in SA
is much lower compared with CA. Mortality rates are comparable. A review which
included all currently available comparative data of SA and CA only showed
significantly more pacemaker implantations in the SA group but no differences
in other major complications.
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 invasive treatment 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
- Patients with any contra-indications for VATS such as pleural adhesions, elevated hemidiaphragm or prior lung/cardiac surgery
- Active infection or sepsis
- Body mass index> 40
- mitral or aortic valve regurgitation above grade 2
- moderate to severe mitral or aortic stenosis
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 | NL51954.041.15 |
| Other | volgt |