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SMART-SF Radiofrequency Ablation Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359890
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : October 17, 2017
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : November 8, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH® SF family of contact force sensing catheters (study device)
Device: THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
Radiofrequency Ablation Treatment
Other Name: Pulmonary vein isolation




Primary Outcome Measures :
  1. Percentage of Participants With Early Onset Primary Adverse Events [ Time Frame: Seven days post ablation procedure ]
    Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.


Secondary Outcome Measures :
  1. Percentage of Participants With Non-Primary Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days post Procedure ]
    This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure

  2. Percentage of Participants With Acute Success [ Time Frame: End of procedure ]
    Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).

  3. Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL) [ Time Frame: 12 months ]
    The freedom from documented AF/AT/AFL based on electrocardiographic data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359890


Locations
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United States, California
Scripps Green Hospital
San Diego, California, United States, 92037
Sharp Memorial Hospital
San Diego, California, United States, 92123
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Providence Saint John's Health Center / Pacific Heart Institute
Santa Monica, California, United States, 90404
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
Florida Hospital Orlando
Orlando, Florida, United States, 32803
United States, Georgia
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10003
United States, Pennsylvania
Penn-State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Cardiac Arrhythmia Research Foundation - St. David's
Austin, Texas, United States, 78705
HeartPlace
Bedford, Texas, United States, 76021
Memorial Hermann Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Biosense Webster, Inc.

Additional Information:
Publications:
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT02359890     History of Changes
Other Study ID Numbers: SMART-SF
STSF-162 ( Other Identifier: BiosenseWebster )
First Posted: February 10, 2015    Key Record Dates
Results First Posted: October 17, 2017
Last Update Posted: August 20, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Biosense Webster, Inc.:
Interventional
Radiofrequency ablation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes