Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation (ARTISAN AF)
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 the Biosense ThermoCool ablation catheter for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart). The Biosense ThermoCool catheter is FDA approved for use in ablation therapy. The Hansen Medical Robotic Sensei System and Artisan catheter are approved in Europe for use during ablation procedures. This system has been used to treat atrial fibrillation in over 1000 patients worldwide by navigating existing, approved ablation catheters. In the US the Hansen Sensei System with Artisan catheter has FDA clearance as a robotic delivery system to facilitate manipulation, positioning and control of catheters used to collect electrophysiological data within the heart atria (upper chambers or the heart), but has not been studied or approved in the US for use in ablation treatment. This study is designed to evaluate safety, compatibility and effectiveness when the Hansen system is used with the ThermoCool ablation catheter in the treatment of paroxysmal atrial fibrillation. In this prospective,nonrandomized study, subjects will undergo treatment with robotic delivery of the of the ThermoCool ablation catheter. The primary effectiveness and safety outcomes must meet pre-established Target Performance Goals(chronic success rate is at least 54%; and, the major complication rate is no greater than 16%).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning the Thermocool Catheter in Patients With Paroxysmal Atrial Fibrillation|
- Safety - Incidence of Major Complications [ Time Frame: 0-7 days and 0-180 days ] [ Designated as safety issue: Yes ]
The incidence of Major Complications, including the early onset (within 7 days of the procedure) predefined complications; and, the incidence of esophageal injury or pulmonary vein stenosis through day 180.
Major Complications include the following adverse events.
Major Complications through 0-7 days:
- Myocardial infarction
- Diaphragmatic paralysis
- Transient ischemic attack (TIA)
- Cardiac tamponade
- Hospitalization or Emergency Room visit
- Vascular access complication
- Heart block
- Pulmonary edema
- Pericardial effusion resulting in pericardiocentesis or surgical intervention
Major Complications through 0-180 days:
- Pulmonary vein stenosis
- Atrio-esophageal fistula
- Effectiveness - Chronic Success [ Time Frame: 91 - 365 days ] [ Designated as safety issue: No ]
Chronic Success is defined as:
- Freedom from symptomatic atrial arrhythmias from days 91 - 365.
- No use of Class I or Class III antiarrhythmic medications.
- No more than 2 ablation procedures within 90 days of the initial procedure and no ablation procedures after day 90.
- No use of a non-study device for ablation of any atrial fibrillation target.
- No ablation of an atrial fibrillation target made by manually manipulating the ThermoCool.
- Pulmonary vein isolation of at least 3 out of 4 veins.
- No surgical ablation for atrial arrhythmias within 90 days.
- No DC cardioversion for atrial arrhythmias.
- No catheter or surgical ablation for atrial arrhythmias.
- Chronic Safety [ Time Frame: 8 - 365 days and 181-365 days post-procedure ] [ Designated as safety issue: Yes ]Chronic safety is defined as the incidence of Major Complications during the period from 8-365 days following the initial ablation procedure, with the exception of Pulmonary Vein Stenosis and Atrio-Esophageal Fistula for which the incidence will be reported from 181-365 days post-procedure.
- Acute Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Acute procedural success is defined as the successful ablation of at least 3 of 4 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 ThermoCool Catheter.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Robotic catheter manipulation, Ablation
Subjects will be treated with the ThermoCool Catheter with one of the family of Artisan guide catheters controlled by the Sensei X Robotic Catheter System.
Pulmonary vein isolation is the required ablation procedure.
Hide Detailed Description
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disturbance, increasing in prevalence with age. AF is often associated with structural heart disease, although a substantial proportion of patients with AF have no detectable heart disease. Hemodynamic impairment and thromboembolic events related to AF result in significant morbidity, mortality, and cost. Catheter ablation therapy is widely recognized as a useful modality for patients with fibrillation that are refractory to medical and ICD treatment, and is increasingly used earlier in treatment.
Physicians specializing in Interventional Cardiology (IC) and/or Electrophysiology (EP) are often confronted by the need to precisely place and control a variety of therapeutic and non-therapeutic catheters in the cardiovascular space. A variety of shapeable and steerable sheaths and guide catheters have been developed to meet this need. These manually controlled catheters traditionally rely upon the ability of the experienced physician to apply varying amounts of curvature via pull wires of a steerable catheter. This tip curvature is then used in combination with insertion and torque to manipulate the distal tip of the catheter in a desired fashion. The manual control over the fine movements of the catheter's distal tip typically has limitations for performing complex mapping, ablation and other therapeutic procedures. Maintaining stable tissue contact at the point of ablation is important in achieving efficient heat transfer to tissues without increasing the power requirement, but micro-movement can be difficult to assess. Therefore, stable tissue contact relies on operator skill to exert forces at cardiac tissue that is constantly shifting due to cardio-respiratory movement. Robotic catheter manipulation may be one way to overcome or improve the issue of catheter stability.
In minimally invasive surgery, robotic-assisted control of the surgical instruments has helped physicians perform difficult dexterous surgical tasks safely and efficaciously. Robotic remote control of catheters has recently been introduced to assist physicians in the safe, accurate placement of the distal catheter tip during percutaneous cardiac procedures. In ablative procedures it is not known whether improving catheter tip stability has a significant effect on lesion quality compared to the manual approach, but some recent publications of both animal and human studies comparing the Hansen Sensei Robotic System and Artisan guide catheter to manual delivery of the ablation catheter suggest that contact pressure conferred by the robotic system results in improved lesion delivery compared to a manual approach and that the use of robotic manipulation during ablation procedures has a event rate similar to manual manipulation. It has been the convention to deliver energy for up to 60 seconds for slow pathway modification and accessory pathways to produce irreversible tissue necrosis. One study suggested that by 30 seconds, robotic ablation appears to exceed the manual ablation signal attenuation at 60 seconds. The study confirmed that transmural lesions were produced at 30 seconds of robotic ablation. Therefore, it may be possible to use shorter ablation times or lower power settings for robotic approaches. This may in turn reduce the likelihood of complications for example, the risk of damage to contiguous structures and the risk of steam pop which is most likely to occur after 30 seconds at temperatures greater than 752 F (400 C).
Subjects who satisfy the inclusion and exclusion criteria will be treated with the ThermoCool Catheter with one of the Artisan guide catheters controlled by the Sensei X Robotic Catheter System. Subjects will be treated according to the following schedule.
- Echocardiogram prior to the introduction of the ThermoCool Catheter, for example, TEE, TTE, ICE, or IVUS.
- Echocardiogram 5 minutes after removal of the ThermoCool Catheter, for example, TEE, TTE, ICE, or IVUS.
- 12-Lead ECG prior to leaving the EP lab.
Per the physician's discretion, the following may be performed:
- Venogram or ICE to determine location, morphology, and dimensions of each pulmonary vein.
- Routine EP study.
- Phrenic nerve pacing.
- Esophageal temperature probe.
- 12-Lead ECG.
- Serum creatinine, BUN, CBC.
- Discharge medications to include antiarrhythmic, antiplatelet, and anticoagulants only.
After the index procedure (ablation), subjects will receive follow-up monitoring as follows.
• A phone call will be made to the subject to inquire regarding any adverse events occurring with the first 7 days post-discharge.
Subjects will be asked to return for a follow-up visit at 30 days to evaluate/record:
- NYHA classification.
- Changes in medications (anti-arrhythmic, anti-platelet or anti-coagulants).
- Occurrence of adverse events.
- Physical examination, and
Subjects will be asked to return for a follow-up visit at 90 days.
- Subjects will undergo the same evaluation as at 30 days.
- An event recorder for transtelephonic monitoring (TTM) will be issued to the patient to be used through day 365 (1 year) to document symptomatic recurrence of AF.
As of the 90-day visit, TTM is required weekly for 8 weeks. In addition, the subject should do the TTM for any symptomatic recurrence of AF.
After the weekly TTM for 8 weeks, TTM is required once a month and during any symptomatic recurrence of AF until the end of the study (365-days post-procedure).
Subjects will be asked to return for a follow-up visit at 180 days.
- Subjects will undergo the same evaluation as at 30 days.
- A 24-hour Holter monitor recording will be conducted.
- Cardiac CT or MRI scan will be done to evaluate any pulmonary vein stenosis.
TTM is required once a month and during any symptomatic recurrence of AF until the end of the study (365 days post-procedure).
Subjects will be asked to return for a follow-up visit at 365 days.
- Subjects will undergo the same evaluation as at 30 days.
- A 24-hour Holter monitor recording will be done, and
- Possibly a cardiac CT or MRI scan will be obtained (if a subject had more than 50% narrowing of the a pulmonary vein at the 180-day follow up).
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Kelly Wock 507-255-7456 firstname.lastname@example.org|
|Principal Investigator: Douglas Packer, MD|
|United States, New Jersey|
|Englewood Hospital and Medical Center||Recruiting|
|Englewood, New Jersey, United States, 07631|
|Contact: Meryna Manandhar 201-894-3907 Meryna.email@example.com|
|Principal Investigator: Grant Simons, MD|
|United States, New York|
|Stony Brook Univeristy Medical Center||Recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Joyce Quick, PA 631-444-8485 Joyce.Quick@stonybrookmedicine.edu|
|Principal Investigator: Eric Rashba, MD|
|United States, South Carolina|
|Greenville Memorial Hospital||Recruiting|
|Greenville, South Carolina, United States, 29605|
|Contact: Erikia Channell 864-455-2288 firstname.lastname@example.org|
|Contact: Maureen Coyne 864-455-7727 email@example.com|
|Principal Investigator: Donald Rubenstein, MD|
|Sub-Investigator: Joseph Manfredi, MD|
|United States, Texas|
|Texas Cardiac Arrhythmia Research Foundation (TCARF)||Recruiting|
|Austin, Texas, United States, 78705|
|Contact: Deb Cardinal 512-458-9410 firstname.lastname@example.org|
|Principal Investigator: G. J. Gallinghouse, M.D.|
|The Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Lenis Sosa, BSN, RN, OCN 713-441-3245 email@example.com|
|Principal Investigator: Miguel Valderrábano, MD|
|United States, Virginia|
|Univeristy of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Mary Jane Strickland 434-982-6401 MJS7W@hscmail.mcc.virginia.edu|
|Principal Investigator: J. Michael Mangrum, MD|
|Principal Investigator:||Andrea Natale, M.D.||Texas Cardiac Arrhythmia Research Foundation|
|Study Director:||Brenda Cayme, RN, BSN||Hansen Medical, Inc.|