Clinical trial NCT01122173: Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
Robotic Control
Remote Control
Lead sponsor: Hansen Medical
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety-Incidence of Major Complications
timeFrame: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
measure: Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
timeFrame: 91 - 365 days after the inital ablation procedure
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Day 0
measure: Chronic Safety-Incidence of Major Complications
timeFrame: 8 - 365 days post-procedure
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Heart Hospital
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Livingston
country: United States
facility: Saint Barnabas Heart Center
state: New Jersey
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Arlington
country: United States
facility: Texas Health Arlington Memorial/Heart Place
state: Texas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation (TCARF)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Charlottesville
country: United States
facility: Univeristy of Virginia
state: Virginia
city: Prague
country: Czechia
facility: IKEM, Dept of Cardiology
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Montepríncipe
city: Oxford
country: United Kingdom
facility: John Radcliff Hospital
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Joseph Gallinghouse, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hansen Medical, Inc.
name: Brenda Cayme, RN., BSN
role: STUDY_DIRECTOR
References: