THERMOCOOL SMARTTOUCH for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

Clinical Trial Title

Safety and effectiveness evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter with the TRUPULSE™ Generator for treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF)

National Clinical Trial Number:

NCT06144632

Contact Information

Clinical Trial Protocol Description:

Clinical evaluation of the Biosense Webster Ablation System to demonstrate safety and effectiveness of the system for the treatment of paroxysmal atrial fibrillation (PAF).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are 18-75 years of age.
  • Have received a diagnosis of symptomatic paroxysmal atrial fibrillation (AF).
  • Have had at least two (2) symptomatic AF episodes within last six (6) months.
  • Have at least one (1) AF episode electrocardiographically documented by 12-lead electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within the last 12 months.

You will be excluded from the study if any of the following criteria apply to you:

  • Have AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. (e.g., documented obstructive sleep apnea, acute alcohol toxicity, etc.)
  • Have an anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
  • Have a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except with prior left atrial appendage closure.
  • Have uncontrolled heart failure.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Parikshit Sharma, MD

Contact Information

Nusrat Jahan

Clinical Trial Location

RUSH University Medical Center

Location

RUSH University Medical Center

1620 W Harrison St
Chicago, IL 60612

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