THERMOCOOL® SMARTTOUCH™ Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01677052
• Date of registration: 29/08/2012
• Prospective Registration: No
• Primary sponsor: Biosense Webster, Inc.
• Public title: THERMOCOOL® SMARTTOUCH™ Registry
• Scientific title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry
• Date of first enrolment: August 2012
• Target sample size: 426
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01677052
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Monaco, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the
investigator, are candidates for ablation for atrial fibrillation. Candidates who
have had previous ablation procedures may be included in the registry

- Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV
nodal blocking agents such as beta blockers and calcium channel blockers) as
evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the AAD.

- Subjects must be 18 years of age or older

- Subjects must be able and willing to comply with all pre-, post and follow-up testing
and requirements

- Subjects must provide written informed consent to participate in the registry

Exclusion Criteria:

- Significant congenital anomaly or a medical problem that in the opinion of the
investigator would preclude enrollment in this registry

- History of blood clotting or bleeding abnormalities or contraindication to
anticoagulation (heparin, warfarin, or dabigatran)

- History of a documented thromboembolic event within the past year

- Significant pulmonary disease (eg, 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

- Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg,
ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic
valve)

- Awaiting cardiac transplantation or other cardiac surgery within the next 360 days
(12 months)

- Diagnosed atrial myxoma

- Unstable angina

- Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart
failure

- Acute illness, active systemic infection, or sepsis

- Any other disease or malfunction that would preclude treatment with ablation in the
opinion of the investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Symptomatic Atrial Fibrillation

Primary Outcome(s)

Contact Force [Time Frame: 1 year]

Adverse Events [Time Frame: 1 year]

Acute Success [Time Frame: 1 year]

Secondary ID(s)

STR-148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors