Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01122173|
Recruitment Status : Terminated
First Posted : May 13, 2010
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Device: Ablation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Robotic catheter manipulation, Ablation
To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
Atrial fibrillation ablation procedure
- Safety-Incidence of Major Complications [ Time Frame: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days ]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.
- Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes [ Time Frame: 91 - 365 days after the inital ablation procedure ]The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
- Acute Procedural Success [ Time Frame: Day 0 ]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.
- Chronic Safety-Incidence of Major Complications [ Time Frame: 8 - 365 days post-procedure ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122173
|United States, Arizona|
|Banner Heart Hospital|
|Mesa, Arizona, United States, 85206|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Englewood Hospital and Medical Center|
|Englewood, New Jersey, United States, 07631|
|Saint Barnabas Heart Center|
|Livingston, New Jersey, United States, 07039|
|United States, South Carolina|
|Greenville Memorial Hospital|
|Greenville, South Carolina, United States, 29605|
|United States, Texas|
|Texas Health Arlington Memorial/Heart Place|
|Arlington, Texas, United States, 76012|
|Texas Cardiac Arrhythmia Research Foundation (TCARF)|
|Austin, Texas, United States, 78705|
|Houston Methodist Research Institute|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Univeristy of Virginia|
|Charlottesville, Virginia, United States, 22908|
|IKEM, Dept of Cardiology|
|Gentofte University Hospital|
|Hellerup, Denmark, 2900|
|Hospital Universitario Madrid Montepríncipe|
|John Radcliff Hospital|
|Oxford, United Kingdom, OX39DU|
|Principal Investigator:||Joseph Gallinghouse, M.D.||Texas Cardiac Arrhythmia Research Foundation|
|Principal Investigator:||Andrea Natale, M.D.||Texas Cardiac Arrhythmia Research Foundation|
|Study Director:||Brenda Cayme, RN., BSN||Hansen Medical, Inc.|