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RecruitMe Clinical Trial

Safety and Effectiveness of TactiFlex Ablation Catheter, Sensor Enabled (TactiFlexSE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation(TactiFlex PAF IDE Trial)
TactiFlex Paroxysmal Atrial Fibrillation (PAF) Trial
Sponsor:Abbott
Enrolling:Male and Female Patients
Minimum Age:18 years old
IRB Number:AAAT1582
U.S. Government ID:NCT04356040
Contact: Cathy Moore: 347-514-3366 / cjm2285@cumc.columbia.edu
Additional Study Information:

The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex Ablation Catheter, Sensor-Enabled (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system, is safe and effective for the treatment of drug refractory, symptomatic paroxysmal atrial fibrillation (PAF) when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures. The study is a prospective, non-randomized multi-center clinical investigation. The design includes a main study and a separate substudy. Subjects in the main study are to be treated using the full range of ablation power settings according to the instructions for use. Subjects in the substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts). Contact force-sensing ablation catheter systems are a technology that is growing in adoption for Atrial Fibrilation (AF) ablation. These contact force-sensing catheter systems provide catheter operators additional feedback by allowing the operator to know how much force is being applied by the catheter tip on the cardiac tissue. The TactiCath family of contact force-sensing catheters from Abbott has been studied extensively in human clinical trials and the The latest TactiCathTM contact force sensing catheter from Abbott is the TactiCath SE ablation catheter, which incorporates a magnetic sensor for tracking with the EnSite Precision Mapping System and utilizes a new handle and shaft to improve catheter handling. The TactiCath SE catheter is being investigated by the TactiSense clinical trial. The TactiFlex PAF IDE study will be the first time that the TactiFlex SE ablation catheter has been used in humans. The goal of this clinical trial will be to demonstrate the safety and effectiveness of this catheter for the treatment of sudden occurrences of AF in the worldwide patient population.

Do You Qualify?
Have you been diagnosed with Atrial fibrillation?YesNo
Have you had a tricuspid or mitral valve repair?YesNo
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Investigator
Amardeep Saluja, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Cathy Moore
Email: cjm2285@cumc.columbia.edu
Phone: 347-514-3366