Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Safety and Feasibility of Electrical Isolation of the Superior Vena Cava in Addition to Pulmonary Vein Ablation for Paroxysmal Atrial Fibrillation Using the Cryoballoon: the SAFE-SVC Study.
The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.
Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively
enrolled in our study. After PVI is obtained and proven by entrance- and exit block, the SVC
will be mapped for potentials. If the SVC exhibits electrical activity, isolation will be
attempted performing a single maximum 180 seconds balloon application. A single 180 seconds
application is known to produce a durable lesion. Performing a combined approach (PVI
together with SVC isolation) using the same cryoballoon requires no additional vascular
access. Therefore no significant raise in complications is to be expected. During a second
generation CBA the described rate of complications is to be estimated around 2%. Transient
phrenic nerve palsy in 7.2 %, but reversible in virtually all patients within the end of the
procedure.
To prevent nervous injury the phrenic nerve (PN) will be tested during ablation of the SVC,
in the same fashion as performed systematically during ablation of the right sided pulmonary
veins.
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