A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific). For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.
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ā¢ Primary safety endpoint: Major complications, (SAE) within 30 days
Timeframe: 30 days
ā¢ Primary efficacy endpoint: Acute success of PVI and LAA closure
Timeframe: 30 days
ā¢ Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
Timeframe: 30 days