SMART-SF Radiofrequency Ablation Safety Study



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/22/2018
Start Date:March 1, 2015
End Date:November 8, 2016

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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

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).

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.

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
We found this trial at
17
sites
1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Atlanta, Georgia 30342
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Atlanta, GA
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Atlantis, Florida 33462
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Atlantis, FL
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Austin, TX
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Bedford, Texas 76021
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Bedford, TX
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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Houston, Texas 77030
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Houston, TX
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Minneapolis, MN
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New York, New York 10016
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New York, NY
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Orlando, Florida 32803
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Orlando, FL
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San Diego, California 92037
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Santa Barbara, California 93105
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Santa Barbara, CA
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Santa Monica, CA
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