ClinicalTrials.gov processed this data on June 18, 2013Link to the current ClinicalTrials.gov record.http://clinicaltrials.gov/show/NCT01122173HMP010NCT01122173Use of the Hansen Medical System in Patients With Atrial Fibrillation
ARTISAN AF
A Prospective, Randomized Study of the Hansen System for Introducing and Positioning the Thermocool Catheter in Patients With Atrial FibrillationHansen MedicalIndustryHansen MedicalUnited States: Food and Drug AdministrationYes
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 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 is 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 looking to show safety, compatibility and effectiveness when the
Hansen system is used in conjunction with the ThermoCool ablation catheter in the treatment
of atrial fibrillation. This will be done by to either treatment with manual delivery of the
ThermoCool ablation catheter or treatment with robotic delivery of the of the ThermoCool
ablation catheter.
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 problem 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 convention to deliver energy for up
to sixty 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 30s at
temperatures greater than 400C.
Subjects who satisfy the inclusion and exclusion criteria shall be randomized 2:1 between
the robotic arm and the manual control arm of the trial. Those in the manual control arm
will receive treatment for their arrhythmia per the investigators standard practice and the
labeling for the Navistar ThermoCool. Subjects in the robotic arm will be treated according
to the following parameters:
- Place ablative lesions 1-2 cm outside of the pulmonary veins in order to minimize the
risk of pulmonary vein stenosis.
- Target IntelliSense readings of 10-20g, with a maximum of 40g, during lesion creation.
- Target lesion creation at RF power settings of 20-25W with a nominal maximum power of
30W. Starting at 20-25W in an anatomical region, RF power may be increased after 15
seconds in 5W increments to achieve a transmural lesion as shown by local atrial
electrogram attenuation or splitting. Ablation duration at a single anatomical lesion
location is recommended to be no longer than 30 seconds. If ablation output time for
the RF generator is set for longer than 30 seconds, the ablation catheter should be
moved so that the ablation catheter duration in a particular location doesn't exceed 30
seconds. Remember that stable contact between the catheter tip and the tissue increases
the efficiency of RF power transfer to the tissue.
- For power levels up to 30W, a flow rate of 17 ml/min should be used.
- If the temperature increases to greater than 50°C or the impedance rises 20Ω or more,
the RF application should be terminated immediately, the catheter removed and the
coagulum removed (if present), and irrigation flow confirmed before the catheter is
used again.
After the index procedure, subjects will receive follow-up monitoring as follows:
7 Day: A phone call will be made to the subject to inquire regarding any adverse events and
to assess any change in NYHA classification since discharge.
30 day: Subjects will be asked to return for a follow-up visit at 30 days. At this
follow-up visit, subjects will undergo an evaluation for changes in medications
(anti-arrhythmic, anti-platelet or anti-coagulation) and adverse events, and receive a
physical examination and 12L EKG.
90 day:Subjects will be asked to return for a follow-up visit at 90 days. At this follow-up
visit, subjects will undergo the same evaluation as at 30 days. An event recorder issued to
patient at this visit to be used through day 365 (1 year) to document symptomatic recurrence
of AF.
180 day: Subjects will be asked to return for a follow-up visit at 180 days. At this
follow-up visit, subjects will undergo the same evaluation as at 30 days. In addition a 24
hour Holter monitor recording and a Cardiac CT or MR will be obtained.
365 day: Subjects will be asked to return for a follow-up visit at 365. At this follow-up
visit, subjects will undergo the same evaluation as at 30 days. In addition a 24 hour Holter
monitor recording and a potentially a Cardiac CT or MR will be obtained.
RecruitingMay 2010December 2013December 2013N/AInterventionalAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: TreatmentThe absence of early onset (within 7 days of the ablation procedure) of all Serious Adverse Events as defined in the protocol.0 - 7 daysYesFreedom from symptomatic atrial fibrillation from days 91-365 (chronic procedural success).91 - 365 daysNoAbsence of esophageal injury or pulmonary vein stenosis through day 365.0 - 365 daysYesFreedom from serious adverse events (SAEs) from day 8 through day 365.8 - 365 daysYesAcute pulmonary vein isolation of at least three out of four veins, as documented by testing entrance block, during the procedure.0 daysNo2300Paroxysmal Atrial FibrillationRobotic catheter manipulation for RF AblationExperimentalIntroduce and position ThermoCool remotely through the Artisan Control Catheter.Manual catheter manipulation for RF AblationActive ComparatorIntroduce and position the ThermoCool manually.DeviceRF AblationPV isolation is the required ablation procedure.Robotic catheter manipulation for RF AblationManual catheter manipulation for RF AblationSensei X Robotic Catheter SystemArtisan Control CatheterNaviStar ThermoCool
Inclusion Criteria:
1. Patients with paroxysmal atrial fibrillation who have had two or more spontaneously
terminating episodes of atrial fibrillation, that last longer than 30 seconds and
shorter than 7 days, in the nine months prior to enrollment. At least one episode
must be documented with EKG, TTM, Holter monitor, or telemetry.
2. Failure of at least one Class I - IV anti-arrhythmic drug (AAD) for PAF as evidenced
by recurrent symptomatic PAF, or intolerable side effects due to AAD. AADs are
defined in Appendix B.
3. Signed informed consent.
4. Age 18 years or older
5. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements.
Exclusion Criteria:
1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause.
2. Previous ablation for atrial fibrillation.
3. Atrial fibrillation episodes that last less than 7 days and are terminated by
cardioversion.
4. Previous valvular cardiac surgery procedure.
5. Cardiac artery bypass graft procedure within the previous 180 days.
6. Previous septal defect repair.
7. Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
8. Coronary PTCA/stenting within the previous 180 days.
9. Documented left atrial thrombus on ultrasound imaging (TEE).
10. Documented history of a thrombo-embolic event within the previous year.
11. Diagnosed atrial myxoma.
12. Presence of an implanted ICD.
13. Presence of permanent pacing leads.
14. Significant restrictive, constrictive, or chronic obstructive pulmonary disease or
any other disease or malfunction of the lungs or respiratory system with chronic
symptoms.
15. Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this study.
16. Women who are pregnant.
17. Acute illness or active infection at time of index procedure documented by either
pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11.000 mm3) for
which antibiotics have been or will be prescribed.
18. Creatinine > 2.5 mg/dl (or > 221 µmol/L).
19. Unstable angina.
20. Myocardial infarction within the previous 60 days.
21. Left ventricular ejection fraction less than 40%
22. History of blood clotting or bleeding abnormalities.
23. Contraindication to anticoagulation.
24. Contraindication to computed tomography or magnetic resonance imaging procedures.
25. Life expectancy less than 1 year.
26. Enrollment in another investigational study.
27. Uncontrolled heart failure (NYHA class III or IV heart failure).
28. Presence of an intramural thrombus, tumor, or other abnormality that precludes
catheter introduction or positioning.
29. Presence of a condition that precludes vascular access.
30. Left Atrial size ≥ 50mm.
31. INR greater than 3.0 within 24 hours of procedure.
Both18 YearsN/ANoAndrea Natale, M.D.Principal InvestigatorTexas Cardiac Arrhythmia Research FoundationDale BergmanStudy DirectorHansen Medical, Inc.Stanford Univeristy Medical CenterStanfordCalifornia94305United StatesRecruitingLinda Norton, RN650-725-5597lnorton@stanfordmed.orgAmin Al-Ahmad, MDPrincipal InvestigatorMayo ClinicRochesterMinnesota55905United StatesRecruitingKelly Wock507-255-7456wock.kelly@mayo.eduDouglas Packer, MDPrincipal InvestigatorStony Brook Univeristy Medical CenterStony BrookNew York11794United StatesRecruitingJoyce Quick, PA631-444-8485Joyce.Quick@stonybrookmedicine.eduEric Rashba, MDPrincipal InvestigatorDuke University Health SystemDurhamNorth Carolina27710United StatesRecruitingDebbie Hickey919-668-3524deborah.hickey@duke.eduPatrick Hranitzky, MDPrincipal InvestigatorGreenville Memorial HospitalGreenvilleSouth Carolina29605United StatesRecruitingErikia Channell864-455-2288echannell@ghs.orgMaureen Coyne864-455-7727mcoyne@ghs.orgDonald Rubenstein, MDPrincipal InvestigatorJoseph Manfredi, MDSub-InvestigatorTexas Cardiac Arrhythmia Research Foundation (TCARF)AustinTexas78705United StatesRecruitingDeb Cardinal512-458-9410dscardinal@austinheartbeat.comG. J. Gallinghouse, M.D.Principal InvestigatorHouston MethodistHoustonTexas77030United StatesRecruitingMelinda Tindel713-441-3248MTindel@tmhs.orgMiguel Valderrábano, MDPrincipal InvestigatorUniveristy of VirginiaCharlottesvilleVirginia22908United StatesRecruitingMary Jane Strickland434-982-6401MJS7W@hscmail.mcc.virginia.eduJ. Michael Mangrum, MDPrincipal InvestigatorUnited StatesAugust 2012August 22, 2012May 10, 2010SponsorAtrial FibrillationRobotic ControlRemote ControlYesYesNoAtrial Fibrillation