SMART-SF Radiofrequency Ablation Safety Study

Biosense Webster

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02359890

SMART-SF

STSF-162 (Other Identifier)

Details and patient eligibility

About

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).

Full description

The purpose of this study is to demonstrate the safety of the study device in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 of blood clotting or bleeding abnormalities
MI within the past 2 months
Documented thromboembolic event (including transient ischemic attack (TIA)) within the past 12 months
Rheumatic Heart Disease
Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
Unstable angina
Acute illness or active systemic infection or sepsis
Diagnosed atrial myxoma
Presence of implanted implantable cardioverter defibrillator (ICD)
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
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
Enrollment in an investigational study evaluating another device, biologic, or drug
Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
Presence of a condition that precludes vascular access
Life expectancy or other disease processes likely to limit survival to less than 6 months