SMART-SF Radiofrequency Ablation Safety Study (NCT02359890) | Clinical Trial Compass
CompletedPhase 3
SMART-SF Radiofrequency Ablation Safety Study
165 participantsStarted 2015-03-01
Plain-language summary
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
* Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
* Age 18 years or older
Exclusion Criteria:
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous surgical or catheter ablation for atrial fibrillation
* Amiodarone at any time during the past 3 months
* Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) within the past 2 months
* Any carotid stenting or endarterectomy
* Coronary artery bypass graft (CABG) surgery within the past 6 months
* AF episodes lasting \>7 days
* Documented left atrial (LA) thrombus on imaging
* LA size \>50 mm
* Left ventricular ejection fraction (LVEF) \< 40%
* Contraindication to anticoagulation (heparin or warfarin)
* History oā¦
What they're measuring
1
Percentage of Participants With Early Onset Primary Adverse Events