Currently, no robust clinical data are available comparing interventional ablation strategies in the setting of persistent AF with enlarged Atrium > 4 cm and longstanding persistent AF, which reflects a difficult to treat patient-subgroup.Thus,…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Primary Effectiveness Endpoint is freedom from documented AF/AFL/AT
episodes > 30 seconds through 12 months follow-up, in the absence of Class I or
III AADs (with the exception of previously failed AADs at doses not exceeding
those previously failed).
Secondary outcome
The Secondary Effectiveness Endpoint is freedom from documented AF/AFL/AT) >30
seconds through 24 and 36 months follow-up, in the absence of Class I or III
AADs (with the exception of previously failed AADs at doses not exceeding those
previously failed).
The rhythm status used for evaluation of the Primary and Secondary Endpoint
will be derived from regularly scheduled 48-hour Holter monitoring and any
symptom driven monitoring performed.
Background summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime
risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic
compromises, AF increases the risk of stroke by 5-fold, and is associated with
increases the odds ratio of death to 1.5 in males and 1.9 in females.
Anti-arrhythmic drug (AAD) therapy remains the first line treatment for
AF;however, it does not represent a cure for AF. All AAD therapies used for AF
treatment have significant side effects and they are of marginal effectiveness
in
nearly all patient populations. Atrial pacing and defibrillators do not cure
the arrhythmia and may not result in better quality of life.
Catheter ablation has evolved as a standardized treatment option in paroxysmal
AF supported by the current guidelines. Although pulmonary vein isolation (PVI)
is the cornerstone of all interventional approaches for AF-treatment, no
uniform concept in the setting of the non-paroxysmal forms currently exists.
Especially in the setting of long-standing persistent AF, additional strategies
apart from sole pulmonary vein isolation are required to achieve reasonable
results regarding rhythm control. Due to the advanced electrical and structural
remodeling of the atria, the results of a single catheter ablation for
persistent and longstanding persistent AF are disappointing, and repeated
endocardial procedures are required in most patients. Due to these
shortcomings, minimally invasive endoscopic surgical techniques applied
epicardially have gained attention with good results in this difficult to treat
patient population. The combination of initial epicardial (surgical) ablation
followed by endocardial (catheter) ablation (staged hybrid ablation) is
expected to be most efficacious in avoiding lesion gaps and providing the most
complete lesion set for effective treatment of the arrhythmia.
Hybrid ablation procedures are currently being performed as standard practice
by teams of surgeons and electrophysiologists to improve on the efficacy in the
treatment of Persistent and Longstanding Persistent AF patients which currently
represent a group of patients with less effective treatment alternatives.
Study objective
Currently, no robust clinical data are available comparing interventional
ablation strategies in the setting of persistent AF with enlarged Atrium > 4 cm
and longstanding persistent AF, which reflects a difficult to treat
patient-subgroup.
Thus, it is the aim of the present randomized study to compare the effects of
combined epicardial endoscopic surgical and endocardial catheter techniques vs
standard endocardial catheter ablation strategies with regard to safety,
efficacy and quality of life. Also, effects on health economics of the two
treatment strategies will be evaluated
Study design
A total of 210 eligible patients will be randomized (2:1 ratio).
140 patients in the hybrid ablation arm, 70 in the catheter ablation arm.
For each patient, the study duration will be 3.5 years (42 months).
Subjects will be followed at discharge and at 3 and 6 months from the index
procedure: during this interval, the study ablation treatment will be
completed. The 6 month visit is the starting point of the follow-up period that
lasts for additional 3 years and is defined as T0. During the follow-up period,
patients will be evaluated at 6 and 12 months, and yearly thereafter, until 3
years after completion of the treatment phase.
At follow-up visits after hospital discharge, patients will undergo noninvasive
routine diagnostic tests including 48 hour holter monitoring at several
timepoints. To ensure consistent data an independent ECG/holter core laboratory
will be used to provide the holter monitoring devices and perform ECG analysis
and symptom driven analysis.
Intervention
hybrid ablation versus standard catheterablation.
For the endoscopic epicardial surgery of patients in the hybrid arm CE marked
AtriCure devices will be used for the ablation procedure.
Endoscopic surgery will include a minimum lesion set including a PV isolation
by the means of a box lesion (right and left epicardial isolation of the PVs,
superior and inferior connecting lines) and exclusion of the left atrial
appendage if considered safe by the surgeon under general anesthesia.
Additional lesions may be performed, based on standard practice at the
interventional sites.
Catheter ablation will be performed using standard endocardial transvenous
technique of PV isolation and possibly additional ablations on physician*s
discretion / center's strategy which are in accordance with current guidelines.
For details refer to section 7 of the Protocol.
Study burden and risks
Burden for the patient is limited to the completion of the SF12 questionnaire
at 6 visits.
Other assessments and treatments are in line with current treatment for the
patients condition.
At this moment both catheter and hybrid ablation are used but no robust data is
available that compares both techniques in the difficult to treat patient group
in this study.
Schiphol Boulevard 127
Schiphol 1118 BG
NL
Schiphol Boulevard 127
Schiphol 1118 BG
NL
Listed location countries
Age
Inclusion criteria
Patients with Persistent and Longstanding Persistent Atrial Fibrillation
Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
Exclusion criteria
1. Patient has longstanding persistent AF > 10 years
2. Patient presenting with paroxysmal AF
3. Patient with persistent AF and a LA-diameter <= 4cm
4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible
or non-cardiovascular cause
Design
Recruitment
Medical products/devices used
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 | NL54331.100.15 |