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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hansen Medical
ClinicalTrials.gov Identifier:
NCT01122173
First received: May 10, 2010
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
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).

Condition Intervention
Paroxysmal Atrial Fibrillation
Device: Ablation

Study Type: Interventional
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 RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Hansen Medical:

Primary Outcome Measures:
  • Safety - Incidence of Major Complications [ Time Frame: within 7 days of the ablation procedure ] [ Designated as safety issue: Yes ]
    The incidence of Major Complications

  • Effectiveness- Freedom from symptomatic atrial fibrillation (AF), atrial flutter, and atrial tachycardia episodes [ Time Frame: 91 - 365 days after the inital ablation procedure ] [ Designated as safety issue: No ]
    Freedom from symptomatic atrial fibrillation (AF), atrial flutter, and atrial tachycardia episodes


Secondary Outcome Measures:
  • Acute Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Acute pulmonary vein isolation of at least three out of four veins

  • Chronic Safety - Incidence of Major Complications [ Time Frame: 8 - 365 days post-procedure ] [ Designated as safety issue: No ]
    Incidence of Major Complications


Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robotic catheter manipulation, Ablation
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.
Device: Ablation
Atrial fibrillation ablation procedure
Other Names:
  • Sensei X Robotic Catheter System
  • Artisan Control Catheter
  • RF Ablation Catheters

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122173

Locations
United States, Arizona
Banner Heart Hospital
Mesa, Arizona, United States, 85206
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Saint Barnabas Heart Center
Livingston, New Jersey, United States, 07039
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
United States, Texas
Texas Health Arlington Memorial/Heart Place
Arlington, Texas, United States, 76012
Texas Cardiac Arrhythmia Research Foundation (TCARF)
Austin, Texas, United States, 78705
Houston Methodist Research Institute
Houston, Texas, United States, 77030
United States, Virginia
Univeristy of Virginia
Charlottesville, Virginia, United States, 22908
Czech Republic
IKEM, Dept of Cardiology
Prague, Czech Republic
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Spain
Hospital Universitario Madrid Montepríncipe
Madrid, Spain
United Kingdom
John Radcliff Hospital
Oxford, United Kingdom, OX39DU
Sponsors and Collaborators
Hansen Medical
Investigators
Principal Investigator: Joseph Gallinghouse, M.D. Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Andrea Natale, M.D. Texas Cardiac Arrhythmia Research Foundation
Study Director: Brenda Cayme, RN., BSN Hansen Medical, Inc.
  More Information

Responsible Party: Hansen Medical
ClinicalTrials.gov Identifier: NCT01122173     History of Changes
Other Study ID Numbers: HMP010 
Study First Received: May 10, 2010
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Hansen Medical:
Atrial Fibrillation
Robotic Control
Remote Control

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016