The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
The purpose of this study is to evaluate safety and acute performance of the THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode in the treatment of Paroxysmal Atrial Fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures. The QDOT-FAST study is a prospective, multi-center, non-randomized, interventional clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
Elisabethinen Hospital
Linz, Austria
OLV Aalst
Aalst, Belgium
AZ Sint-Jan
Bruges, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Number of Subjects Achieved Acute Procedural Success
Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.
Time frame: Day 1
Incidence of Acute Safety
Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.
Time frame: 7 days post-procedure
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Ceské Budejovice Hospital
České Budějovice, Czechia
Na Homolce
Prague, Czechia
Ospedale F Miulli
Bari, Italy