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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01585961
First received: March 14, 2012
Last updated: January 20, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
Paroxysmal Arrhythmia
Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Total Fluoroscopy Time [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
    The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.

  • Total Procedure Time [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: Yes ]
  • Acute Procedural Success [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
    Confirmation of entrance and/or exit block across all targeted pulmonary veins.


Secondary Outcome Measures:
  • Mean Number of Radiofrequency (RF) Applications [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
    RF applications is defined as the number of times RF energy is delivered during the procedure.

  • Total Radiofrequency (RF) Time [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
    Total RF time is defined as the total time that RF energy is delivered during the procedure.

  • Fluid Volume Delivered Via Ablation Catheter [ Time Frame: Day 0 (procedure) ] [ Designated as safety issue: No ]
  • Number of Patients With Repeat Ablations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Post-procedure AF Symptoms [ Time Frame: 12 Month Visit ] [ Designated as safety issue: No ]
    Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit

  • Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit [ Time Frame: 12 Month Visit ] [ Designated as safety issue: No ]
  • Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation [ Time Frame: 12 Month Visit ] [ Designated as safety issue: No ]
  • Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation [ Time Frame: 12 Month Visit ] [ Designated as safety issue: No ]
  • Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [ Time Frame: Screening to 12 Month Visit ] [ Designated as safety issue: No ]
    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.


Enrollment: 511
Study Start Date: April 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585961

  Show 45 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Gery Tomassoni, MD Central Baptist Hospital
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: Robert Fishel, MD JFK Medical Center
Principal Investigator: Kenneth Civello, MD Cardiovascular Research Foundation of Louisiana
Principal Investigator: Gaurang Gandhi, MD Bethesda North Hospital
Principal Investigator: Alexandru Costea, MD University of Cincinnati
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: Charles Athill, MD San Diego Cardiac 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
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01585961     History of Changes
Other Study ID Numbers: ThermoCool SF Phase IV
Study First Received: March 14, 2012
Results First Received: January 13, 2015
Last Updated: January 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Biosense Webster, Inc.:
Symptomatic paroxysmal
Atrial fibrillation
Observational
Acute procedural outcomes
Ablation
Drug refractory
Arrhythmia Recurrent
Symptomatic

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 26, 2015