Clinical trial NCT01677052: THERMOCOOL® SMARTTOUCH™ Registry
Official title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target enrollment for this registry is 650 subjects. Of the 650 subjects enrolled, at least 250 will have paroxysmal atrial fibrillation.

Brief summary: The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.


Eligibility 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

Primary outcomes:
measure: Acute Success
timeFrame: 1 year
measure: Contact Force
timeFrame: 1 year
measure: Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: De Potter T, Van Herendael H, Balasubramaniam R, Wright M, Agarwal SC, Sanders P, Khaykin Y, Latcu DG, Maury P, Pani A, Hayes J, Kalman J, Nery P, Duncan E. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018 Nov 1;20(FI_3):f410-f418. doi: 10.1093/europace/eux290.