Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
+12 other locations
AN
JG
Overseen byJoseph Gallinghouse, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Hansen Medical
No Placebo Group
Trial Summary
What is the purpose of this trial?
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).
Research Team
BC
Brenda Cayme, RN., BSN
Principal Investigator
Hansen Medical, Inc.
AN
Andrea Natale, M.D.
Principal Investigator
Texas Cardiac Arrhythmia Research Foundation
JG
Joseph Gallinghouse, M.D.
Principal Investigator
Texas Cardiac Arrhythmia Research Foundation
Eligibility Criteria
Inclusion Criteria
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.
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.
Signed informed consent.
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Treatment Details
Interventions
- Artisan Catheter (Catheter)
- Hansen Medical Sensei Robotic System (Robotic System)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Robotic catheter manipulation, AblationExperimental Treatment1 Intervention
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.
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Who Is Running the Clinical Trial?
Hansen Medical
Lead Sponsor
Trials
5
Recruited
690+