Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study.
BACKGROUND
Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF). However, there is some evidence for an ablation associated (silent) stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF) is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF.


METHODS
Patients are randomized 1:1 for the Arctic Front(R) or the HD Mesh Ablator(R) catheter for left atrial catheter ablation (LACA). The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI), neuro(psycho)logical tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled.


CONCLUSIONS
Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion.


BACKGROUND
clinicaltrials.gov NCT01061931.
Haeusler
Karl Georg
KG
Department of Neurology, Charité - University Medicine Berlin, Germany. georg.haeusler@charite.de
Koch
Lydia
L
Ueberreiter
Juliane
J
Endres
Matthias
M
Schultheiss
Heinz-Peter
HP
Heuschmann
Peter U
PU
Schirdewan
Alexander
A
Fiebach
Jochen B
JB
D001281:Atrial Fibrillation / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D001921:Brain / Q000473:pathology; D017115:Catheter Ablation / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D002404:Catheterization / Q000009:adverse effects* / Q000295:instrumentation; D003935:Diagnostic Techniques, Cardiovascular; D007839:Functional Laterality; D006321:Heart / Q000503:physiopathology; D006801:Humans; D008279:Magnetic Resonance Imaging; D008991:Monitoring, Physiologic; D009483:Neuropsychological Tests; D011446:Prospective Studies; D019736:Prostheses and Implants; D020521:Stroke / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology; D016896:Treatment Outcome