NCT01677052CompletedNot Applicable
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 426
- Primary Endpoint
- Acute Success
Study Overview
Brief Summary
The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Acute Success
Time Frame: 1 year
Confirmation of entrance block in the pulmonary veins (acute success)
Contact Force
Time Frame: 1 year
Contact force during ablation procedures
Adverse Events
Time Frame: 1 year
Procedural complications and adverse events throughout the registry
Secondary Outcomes
No secondary outcomes reported
Investigators
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