This trial is active, not recruiting.

Condition paroxysmal atrial fibrillation
Treatment ablation
Sponsor Hansen Medical
Start date July 2013
End date December 2016
Trial size 150 participants
Trial identifier NCT01122173, HMP010


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
ablation Sensei X Robotic Catheter System
Atrial fibrillation ablation procedure

Primary Outcomes

Safety - Incidence of Major Complications
time frame: within 7 days of the ablation procedure
Effectiveness- Freedom from symptomatic atrial fibrillation (AF), atrial flutter, and atrial tachycardia episodes
time frame: 91 - 365 days after the inital ablation procedure

Secondary Outcomes

Acute Procedural Success
time frame: Day 0
Chronic Safety - Incidence of Major Complications
time frame: 8 - 365 days post-procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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 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 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.

Additional Information

Official title A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation
Principal investigator Joseph Gallinghouse, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hansen Medical.