Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment thermocool® smarttouch® (rf ablation treatment)
Phase phase 2/phase 3
Sponsor Biosense Webster, Inc.
Start date March 2015
End date September 2015
Trial size 165 participants
Trial identifier NCT02359890, SMART-SF, STSF-162

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
thermocool® smarttouch® (rf ablation treatment) Pulmonary vein isolation
Radiofrequency Ablation Treatment

Primary Outcomes

Measure
Safety as measured by incidence of any early onset primary adverse events
time frame: 7 days

Secondary Outcomes

Measure
Periprocedural Safety procedure: Incidence of all serious and non-serious adverse events
time frame: 30 days
Acute Effectiveness: Isolation of all pulmonary veins demonstrated by entrance block confirmation
time frame: intraoperative
Effectiveness Endpoint: freedom from documented atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Safety Assessment of the THERMOCOOL® SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Biosense Webster, Inc..