Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation

Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:July 2013
End Date:April 2017

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A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation

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.

Inclusion Criteria:

1. Subjects 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 AADs. 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

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

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 365 days.

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 medications.

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.
We found this trial at
Austin, Texas 78705
Phone: 512-458-9410
Austin, TX
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Arlington, Texas 76012
Phone: 817-250-4960
Arlington, TX
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Charlottesville, Virginia 22908
Phone: 434-982-6401
Charlottesville, VA
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Phone: 201-894-3907
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
Englewood, NJ
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Phone: 864-455-2288
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
Greenville, SC
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Houston, Texas 77030
Phone: 713-441-3248
Houston, TX
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Livingston, New Jersey 07039
Phone: 973-271-1756
Livingston, NJ
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Mesa, Arizona 85206
Phone: 480-854-5213
Mesa, AZ
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Phone: 420236055006
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Rochester, Minnesota 55905
Phone: 507-255-7456
Rochester, MN
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