This trial is active, not recruiting.

Condition atrial fibrillation
Treatment thermocool® smarttouch™
Phase phase 4
Sponsor Biosense Webster, Inc.
Start date July 2015
End date June 2017
Trial size 200 participants
Trial identifier NCT02485925, BW-201501


This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
thermocool® smarttouch™ Pulmonary vein isolation
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)

Primary Outcomes

Freedom from Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes
time frame: 12 month

Secondary Outcomes

Acute Success
time frame: 0.5 hour
Contact Force (CF)
time frame: 3, 6, 9 and 12 point position
Force Time Integral (FTI)
time frame: 3, 6, 9 and 12 point position
Number of PV Reconnection
time frame: 3, 6, 9 and 12 point position
Percentage of PV Reconnection
time frame: 3, 6, 9 and 12 point position
Sites of PV Reconnection
time frame: 3, 6, 9 and 12 point position
Total Procedure Time
time frame: Procedure
Ablation (RF) Time
time frame: Procedure
Fluoroscopy Time
time frame: Procedure
Incidence of Adverse Events (AEs)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age 18 years or older 2. Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD 3. Patients with paroxysmal AF eligible for catheter ablation 4. Patients with symptomatic PAF who have had at least one documented AF episode in the six (6) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM) 5. Able and willing to comply with all pre-, post- and follow-up testing and requirements 6. Be able to sign IRB/EC-approved informed consent form Exclusion Criteria: 1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 2. Previous surgical or catheter ablation for AF 3. Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months. 4. Any carotid stenting or endarterectomy. 5. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months) 6. AF episodes lasting longer than 7 days or terminated via cardioversion 7. Documented left atrial thrombus on imaging 8. Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV 9. Myocardial Infarction within the previous 60 days (2 months) 10. Documented thromboembolic event (including TIA) within the past 12 months 11. Rheumatic heart disease 12. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months) 13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. 14. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study 15. Active illness or active systemic infection or sepsis 16. Diagnosed atrial myxoma 17. Unstable angina within the past 60 days (2 months) 18. History of blood clotting or bleeding abnormalities 19. Life expectancy less than 365 days (12 months) 20. Hypertrophic obstructive cardiomyopathy 21. Presence of implanted ICD 22. Contraindication to anticoagulation 23. Contraindication to isoproterenol 24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation 25. Women who are pregnant and/or breast feeding 26. Presence of a condition that precludes vascular access. 27. Patients presenting contraindications for study catheter(s), as indicated in the respective Instructions For Use 28. Enrollment in an investigational study evaluating another device, biologic, or drug.

Additional Information

Official title 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
Principal investigator Congxin Huang
Description The purpose of this study is to assess the effectiveness and safety of the THERMOCOOL® SMARTTOUCH™ catheter in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) undergoing CPVI.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Biosense Webster, Inc..