Clinical trial NCT02359890: SMART-SF Radiofrequency Ablation Safety Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Interventional
Radiofrequency ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Early Onset Primary Adverse Events
timeFrame: Seven days post ablation procedure
Secondary outcomes:
measure: Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)
timeFrame: Up to 30 days post Procedure
measure: Percentage of Participants With Acute Success
timeFrame: End of procedure
measure: Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
citation: Oza SR, Hunter TD, Biviano AB, Dandamudi G, Herweg B, Patel AM, Pollak SJ, Wang H, Fishel RS. Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 observational registry studies. J Cardiovasc Electrophysiol. 2014 Aug;25(8):852-858. doi: 10.1111/jce.12403. Epub 2014 Apr 9.