NAVISTAR® THERMOCOOL® SF Catheter: Observational Study (SFAF)

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Paroxysmal Arrhythmia
• Intervention / Treatment: Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)

Detailed Description

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

• Study Type: Observational
• Enrollment (Actual): 511

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart Institute, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Hospital
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare Research Institute
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinical Research
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • San Francisco, California, United States, 94143
      • UCSF Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Daytona Beach, Florida, United States, 32117
      • Florida Hospital Memorial Medical Center
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Ambulatory Care, Inc.
    • Largo, Florida, United States, 33774
      • Largo Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital - Orlando
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Hospital of Atlanta
    • Savannah, Georgia, United States, 31419
      • Cardiology Associates of Savannah
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Springfield, Illinois, United States, 62701
      • Prairie Education And Research Cooperative
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Medical Group, Llc
  • Iowa
    • Iowa City, Iowa, United States, 55242
      • University of Iowa Hospital & Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospitals
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
    • Louisville, Kentucky, United States, 40207
      • Baptist Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Cardiovascular Research Foundation of Louisiana
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Minnesota
    • St. Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Mid American Heart Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan LGH Heart Institute
    • Omaha, Nebraska, United States, 68131
      • The Cardiac Center of Creighton University
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital, Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare Systems
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Central Bucks Specialists, LTD
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt Heart and Vascular Institute
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center
    • Grapevine, Texas, United States, 76501
      • Plaza Medical Center
    • Houston, Texas, United States, 77030
      • Texas Heart Institute at St. Luke's Episcopal Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • Cardiac Study Center
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Memorial Hospital, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.

Description

Inclusion Criteria:

• Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
• Age 18 years or older
• Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous ablation for atrial fibrillation
• Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
• Uncontrolled heart failure, or NYHA Class III or IV heart failure
• Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
• Contraindication to anticoagulation
• Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
• Awaiting cardiac transplantation
• Heart disease in which corrective surgery is anticipated within 6 months
• Enrollment in investigational drug, biologic or device study
• Subjects unwilling to comply with protocol or follow-up requirements
• Patients who are pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Catheter Ablation; These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device.	Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter); Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Fluoroscopy Time	The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.	Day 0 (procedure)
Total Procedure Time		Day 0 (procedure)
Acute Procedural Success	Confirmation of entrance and/or exit block across all targeted pulmonary veins.	Day 0 (procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Radiofrequency (RF) Applications	RF applications is defined as the number of times RF energy is delivered during the procedure.	Day 0 (procedure)
Total Radiofrequency (RF) Time	Total RF time is defined as the total time that RF energy is delivered during the procedure.	Day 0 (procedure)
Fluid Volume Delivered Via Ablation Catheter		Day 0 (procedure)
Number of Patients With Repeat Ablations		1 year
Post-procedure AF Symptoms	Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit	12 Month Visit
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit		12 Month Visit
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation		12 Month Visit
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation		12 Month Visit
Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.	Screening to 12 Month Visit

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Scott Pollak, MD, Florida Hospital - Orlando; Principal Investigator: Andy Tran, MD, Scottsdale Healthcare Research Institute; Principal Investigator: Saumil Oza, MD, St. Vincent's Ambulatory Care, Inc.; Principal Investigator: Steven Compton, MD, Alaska Heart Institute, LLC; Principal Investigator: Anshul Patel, MD, St. Joseph's Hospital of Atlanta; Principal Investigator: Kenneth Civello, MD, Cardiovascular Research Foundation of Louisiana; Principal Investigator: Gaurang Gandhi, MD, Bethesda North Hospital; Principal Investigator: Sreedhar Billakanty, MD, Riverside Methodist Hospital; Principal Investigator: H. James Wang, MD, Florida Hospital Memorial Medical Center; Principal Investigator: John Harding, MD, Central Bucks Specialists, Ltd.; Principal Investigator: Mohammed Khan, MD, Alexian Brothers Medical Center; Principal Investigator: Vijay Jayachandran, MD, Baylor All Saints Medical Center; Principal Investigator: Sree Karanam, MD, Lutheran Medical Group, Llc; Principal Investigator: M. Craig Delaughter, MD, Plaza Medical Center; Principal Investigator: Mohammad Jazayeri, MD, Bellin Memorial Hospital, Inc.; Principal Investigator: Abdi Rasekh, MD, Texas Heart Institute at St. Luke's Episcopal Hospital; Principal Investigator: Scott Allison, MD, Heart Center Research, LLC; Principal Investigator: Alexander Mazur, MD, University of Iowa Hospital & Clinics; Principal Investigator: Dhanunjaya Lakkireddy, MD, University of Kansas Hospitals; Principal Investigator: Alan Wimmer, MD, St. Luke's Hospital Mid American Heart Institute; Principal Investigator: Ali Hamzei, MD, Scripps Clinical Research; Principal Investigator: Shalin Shah, MD, Largo Medical Center; Principal Investigator: Michael Kutayli, MD, Bryan LGH Heart Institute; Principal Investigator: John Mandrola, MD, Baptist Hospital; Principal Investigator: Stuart Beldner, MD, North Shore University Hospital; Principal Investigator: Joshua Moss, MD, University of Chicago; Principal Investigator: Greg Bashian, MD, Centennial Heart; Principal Investigator: Patrick Whalen, MD, Vanderbilt Heart and Vascular Institute; Principal Investigator: Angelo Biviano, MD, New York Presbyterian Hospital, Columbia University Medical Center; Principal Investigator: Hussam Abuissa, MD, The Cardiac Center of Creighton University; Principal Investigator: Sumeet Mainigi, MD, Albert Einstein Medical Center; Principal Investigator: Edward Gerstenfeld, MD, UCSF Medical Center; Principal Investigator: Michael Chisner, MD, Cardiology Associates of Savannah; Principal Investigator: Vijendra Swarup, MD, Arizona Heart Hospital; Principal Investigator: Ziad Issa, MD, Prairie Education And Research Cooperative; Principal Investigator: Tariq Salam, MD, Cardiac Study Center; Principal Investigator: Sung Lee, MD, Washington Adventist Hospital; Principal Investigator: M. Magdy Migeed, MD, Genesis Healthcare Systems; Principal Investigator: Jonathan Sussman, MD, Morristown Medical Center; Principal Investigator: Bengt Herweg, MD, Tampa General Hospital; Principal Investigator: Pierce Vatterott, MD, United Heart and Vascular Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: April 25, 2012
• First Posted (ESTIMATE): April 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Observational; Ablation; Symptomatic; Symptomatic paroxysmal; Acute procedural outcomes; Drug refractory; Arrhythmia Recurrent
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: ThermoCool SF Phase IV