A Study of the Use of the Hansen Medical System in Patients with Paroxysmal Atrial Fibrillation

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Subjects with paroxysmal atrial fibrillation who have had two or more spontaneously terminating episodes of atrial fibrillation
    • 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.
  • 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
  • Signed informed consent.
  • Age 18 years or older
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

 

Exclusion Criteria

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  • Previous ablation for atrial fibrillation.
  • Atrial fibrillation episodes that last less than 7 days and are terminated by cardioversion.
  • Previous valvular cardiac surgery procedure.
  • Cardiac artery bypass graft procedure within the previous 180 days.
  • Previous septal defect repair.
  • Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
  • Coronary PTCA/stenting within the previous 180 days.
  • Documented left atrial thrombus on ultrasound imaging (TEE).
  • Documented history of a thrombo-embolic event within the previous 365 days.
  • Diagnosed atrial myxoma.
  • Presence of an implanted ICD.
  • Presence of permanent pacing leads.
  • Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any other disease or malfunction of the lungs or respiratory system with chronic symptoms.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  • Women who are pregnant.
  • 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.
  • Creatinine > 2.5 mg/dl (or > 221 µmol/L).
  • Unstable angina.
  • Myocardial infarction within the previous 60 days.
  • Left ventricular ejection fraction less than 40%
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation medications.
  • Contraindication to computed tomography or magnetic resonance imaging procedures.
  • Life expectancy less than 1 year.
  • Enrollment in another investigational study.
  • Uncontrolled heart failure (NYHA class III or IV heart failure).
  • Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.
  • Presence of a condition that precludes vascular access.
  • Left atrial size ≥ 50mm.
  • INR greater than 3.0 within 24 hours of procedure.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Packer, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20151961

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