SMART-SF Radiofrequency Ablation Safety Study

August 17, 2018 updated by: Biosense Webster, Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Seven days post ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 days post Procedure
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).
End of procedure
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 8, 2016

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 17, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-SF
  • STSF-162 (Other Identifier: BiosenseWebster)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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