The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).
Subjects who satisfy the inclusion and exclusion criteria will be treated with an RF ablation catheter and Artisan guide catheters controlled by the Sensei X Robotic Catheter System. Subject will be followed for a period of one year post ablation procedure. Follow up visit time frames will be conducted at 7-day, 30-day, 90-day, 180-day and 365-day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Atrial fibrillation ablation procedure
Banner Heart Hospital
Mesa, Arizona, United States
Mayo Clinic
Rochester, Minnesota, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Safety-Incidence of Major Complications
The primary safety endpoint was defined as the incidence of major complications, including all early onset (within 7 days of the ablation procedure) major complications, and the incidence of esophageal injury or pulmonary vein stenosis through 180 days.
Time frame: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
Time frame: 91 - 365 days after the inital ablation procedure
Acute Procedural Success
Acute procedural success is defined as the successful ablation of at least three of four pulmonary veins as shown by pulmonary vein entrance block per vein during the initial ablation procedure. A subject is considered to be an acute procedural failure if acute procedural success cannot be obtained by using the Hansen system and, as a result, manual manipulation is needed to complete the ablation procedure with the ablation catheter.
Time frame: Day 0
Chronic Safety-Incidence of Major Complications
Chronic safety is defined as the incidence of Major Complications during the period from 8 - 365 days following the initial ablation procedure (excluding pulmonary vein stenosis and atrio-esophageal fistula from 8 - 180 days, which are included in the primary safety endpoint). The incidence of pulmonary vein stenosis and atrioesophageal fistula is included during the period from 181 - 365 days.
Time frame: 8 - 365 days post-procedure
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Saint Barnabas Heart Center
Livingston, New Jersey, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Texas Health Arlington Memorial/Heart Place
Arlington, Texas, United States
Texas Cardiac Arrhythmia Research Foundation (TCARF)
Austin, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Univeristy of Virginia
Charlottesville, Virginia, United States
IKEM, Dept of Cardiology
Prague, Czechia
...and 3 more locations