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).

Stanford is now accepting new patients for this trial. Please contact Amin Al-Ahmad at 6507237111 for more information.

Investigator(s):

Intervention(s):

  • device : Ablation

Phase: N/A

Eligibility

Ages Eligible For Study:

18 Years - N/A

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.

External Links

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Contact information

Primary Contact:

Amin Al-Ahmad 6507237111

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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