The Effectiveness and Safety in the Treatment of Circumferential Pulmonary Vein Isolation (CPVI) for Symptomatic Paroxysmal Atrial Fibrillation With THERMOCOOL® SMARTTOUCH™ Catheter in China, A Multi-center Clinical Registry Study
Phase: PHASE4
Conditions: Atrial Fibrillation
Sponsor: Biosense Webster, Inc.



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Johnson & Joh nson Medica l (Sha ngha i) Ltd 
Protocol No:  BW-201501 
 
 
1.0 Introduction 
1.1Background 
Redacted 
 
1.2 Rationale 
Redacted 
 
1.3 Device Description 
 
The com mercia lly avai la ble TH ERMOCOOL" SMARTTOUCH'" catheter Diagnostic /Ablation 
Deflecta ble Tip Catheter with Contact Force Sensing Ca pa bility is the only study catheter to be 
used in this study. 
The catheter is a mu lti-electrod e lu m ina l cat heter with a def lecta ble 3.5 m m tip designed to 
fa cilitate electro physiological mapping of the heart and to transmit RF cu rrent to the catheter 
tip electrode for ablation pu rposes. The catheter shaft measu res 7.5 F with 8.0 F ring 
electrodes. For ablation, the catheter Is used in conjunction with an R F generator and a 
dispersive pad (indifferent electrode). 
The catheter has force sensing technology t hat provides a rea l-time measu rement of contact 
force between the catheter ti p and the beati ng heart wal l. It is specifica lly designed to allow 
full integration with t he electro-anatomic ma ppi ng system, which provides both graphica l and 
n u merica l displays of CF and the force vector in real time; thus both magnitude and direction 
of the force a re visua lized via a 3-D vector. This catheter is a mod ification of the widely used 
irrigated-ti p bid irectional diagnostic/ablation catheter (THERMOCOOL ® EZ Steer'", Biosense 
Webster) and diagnostic/ablation I catheter (NAVISTAR THERMOCOOL '", Biosense Webster), 
using a simila r irrigation and bidi rectional system. Only the distal ti p has been modified with 
additiona l elements to accom plish CF sensing. 
 
 
 

Johnson & Johnson Medical (Shanghai) Ltd 
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Protocol No:  BW-201501 
Version: 2.0, 2016-01-07 
CONFIDE NTIAL 
 
• Efforts to maintain contact with all treated subjects who fail to comply with the 
follow-up requirements. Before a subject may be classified as 'lost to follow-up',the 
Investigator or authorized personnel should document at least four attempts to 
contact the subject: three (3) by documented phone calls and one (1) written 
attempt sent by registered mail. If the subject is contacted but does not wish to 
complete the required follow-up, investigator will be asked to provide a written 
statement confirming that he/she is no longer willing to participate in the study. 
• Prepare a final report and periodic IRB updates as required. 
 
 
11.3 Sponsor Responsibilities 
 
• Redacted 
 
 
11.4 The CRO Responsibilities 
 
• Redacted 
 
 
11.5 Initiation of the Investigation 
 
The investigational site will undergo an evaluation to ensure that the site has the 
appropriate facilities and personnel to conduct the study in compliance with the 
lnvestigational Plan (protocol). 
The participating site will be provided with the appropriate training prior to 
commencement of the study. To insure uniform data collection and protocol 
compliance, the Sponsor will present a formal educational session to study site 
personnel that will include review of the Clinical Study Protocol, techniques for the 
identification of eligible subjects, instructions on in-hospital data collection, follow­ 
up schedules with the study site coordinators, and regulatory requirements.