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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hansen Medical
Sponsor:
Information provided by (Responsible Party):
Hansen Medical
ClinicalTrials.gov Identifier:
NCT01122173
First received: May 10, 2010
Last updated: February 11, 2015
Last verified: November 2013

May 10, 2010
February 11, 2015
July 2013
June 2015   (final data collection date for primary outcome measure)
  • 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
  • The absence of early onset (within 7 days of the ablation procedure) of all Major Adverse Events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Freedom from symptomatic atrial fibrillation from days 91-365 (chronic procedural success). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Absence of esophageal injury or pulmonary vein stenosis through day 365 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01122173 on ClinicalTrials.gov Archive Site
  • 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
  • Freedom from serious adverse events (SAEs), reported from day 8 through day 365 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute pulmonary vein isolation of at least three out of four veins, as documented by testing entrance block, during the procedure. [ Time Frame: 0 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
Device: Ablation
Atrial fibrillation ablation procedure
Other Names:
  • Sensei X Robotic Catheter System
  • Artisan Control Catheter
  • RF Ablation Catheters
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.
Intervention: Device: Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
November 2016
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States,   Czech Republic,   Denmark,   Spain,   United Kingdom
 
NCT01122173
HMP010
Yes
Hansen Medical
Hansen Medical
Not Provided
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.
Hansen Medical
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP