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

NCT ID: NCT01122173

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-04-30

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ablation

Intervention Type: DEVICE

Atrial fibrillation ablation procedure

Interventions

Ablation

Atrial fibrillation ablation procedure

Intervention Type: DEVICE

Other Intervention Names

Sensei X Robotic Catheter System; Artisan Control Catheter; RF Ablation Catheters

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hansen Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Gallinghouse, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Andrea Natale, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Brenda Cayme, RN., BSN

Role: STUDY_DIRECTOR

Hansen Medical, Inc.

Locations

Banner Heart Hospital

Mesa, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Saint Barnabas Heart Center

Livingston, New Jersey, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Texas Health Arlington Memorial/Heart Place

Arlington, Texas, United States

Texas Cardiac Arrhythmia Research Foundation (TCARF)

Austin, Texas, United States

Houston Methodist Research Institute

Houston, Texas, United States

Univeristy of Virginia

Charlottesville, Virginia, United States

IKEM, Dept of Cardiology

Prague, , Czechia

Gentofte University Hospital

Hellerup, , Denmark

Hospital Universitario Madrid Montepríncipe

Madrid, , Spain

John Radcliff Hospital

Oxford, , United Kingdom

Countries

United States; Czechia; Denmark; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HMP010

Identifier Type: -

Identifier Source: org_study_id