Clinical Trials Directory

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.

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.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amin Al-Ahmad
6507237111
Recruiting

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