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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: October 23, 2014
Last verified: October 2014
  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: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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:
  • Procedural efficiency of fluoroscopy use, fluid volume and procedure time [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Acute Safety - examine impact of confounders such as age, co-morbidities, physician patient volume [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Efficacy of catheter ablation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Confirmation of entrance block.

  • Acute Safety [ Time Frame: Within 7 days of the procedure ] [ Designated as safety issue: Yes ]
    Procedural complications and/or adverse events (including serious adverse events).

  • Procedural Success [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Effectiveness at 1 year following procedure, measured by no recurrence of atrial fibrillation.

  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events (including serious adverse events) throughout observation period

  • Fluid Volume Used [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Fluoroscopy Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Procedure Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Number of RF Applications [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Number of Repeat Ablations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time from Index Ablation Procedure to Repeat Ablation Procedure(s) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Post-procedure Symptoms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Symptoms attributed to paroxysmal atrial fibrillation reported during 1 year follow-up.

  • Number of Subjects Employed Compared to Pre-procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Medication Usage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subject required use of antiarrhythmic drugs during 1 year follow-up.

  • Number of Inpatient Hospital Visits Related to Atrial Fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Number of Outpatient Visits Related to Atrial Fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 508
Study Start Date: April 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter Ablation
These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.
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
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 33 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Sung Lee, MD Washington Adventist Hospital
Principal Investigator: Hussam Abuissa, MD Creighton University Medical Center
Principal Investigator: Scott Allison, MD Huntsville Hospital
Principal Investigator: Charles Athill, MD Sharp HealthCare
Principal Investigator: Greg Bashian, MD Centennial Medical Center
Principal Investigator: Stuart Beldner, MD North Shore University Hospital
Principal Investigator: Sreedhar Billakanty, MD Riverside Methodist Hospital
Principal Investigator: Angelo Biviano, MD New York-Presbyterian Hospital, Columbia Univ MC
Principal Investigator: Michael Chisner, MD St Josephs Hospital - Savannah
Principal Investigator: Kenneth Civello, MD Our Lady of the Lake Regional Medical Center
Principal Investigator: Steven Compton, MD Providence Alaska Medical Center
Principal Investigator: Alexandru Costea, MD The University of Cincinnati
Principal Investigator: M. Craig Delaughter, MD Plaza Medical Center
Principal Investigator: Robert Fishel, MD JFK Medical Center
Principal Investigator: Gaurang Gandhi, MD Bethesda North Hospital
Principal Investigator: Edward Gerstenfeld, MD UCSF Medical Center
Principal Investigator: Ali Hamzei, MD Scripps Memorial Hospital
Principal Investigator: John Harding, MD Doylestown Hospital
Principal Investigator: Bengt Herweg, MD Tampa General Hospital
Principal Investigator: Ziad Issa, MD St John's Hospital
Principal Investigator: Vijay Jayachandran, MD Baylor All Saints Medical Center
Principal Investigator: Mohammad Jazayeri, MD Bellin Memorial Hospital Inc
Principal Investigator: Sree Karanam, MD Lutheran Hospital
Principal Investigator: Mohammed Khan, MD Alexian Brothers Medical Center
Principal Investigator: Michael Kutayli, MD BryanLGH Heart Institute
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Hospital
Principal Investigator: Joseph Levine, MD Saint Francis Memorial Hospital
Principal Investigator: Sumeet Mainigi, MD Albert Einstein Medical Center
Principal Investigator: John Mandrola, MD Baptist Hospital East
Principal Investigator: Alexander Mazur, MD University of Iowa Hospital & Clinics
Principal Investigator: M. Magdy Migeed, MD Genesis Healthcare Systems
Principal Investigator: Joshua Moss, MD University of Chicago
Principal Investigator: Saumil Oza, MD St. Vincent's Medical Center
Principal Investigator: Anshul Patel, MD St. Joseph's Hospital of Atlanta
Principal Investigator: David Pederson, MD The Methodist Hospital System
Principal Investigator: Scott Pollak, MD Florida Hospital Orlando
Principal Investigator: Ishu Rao, MD Community Memorial Hospital
Principal Investigator: Abdi Rasekh, MD St. Luke's Medical Center, Texas
Principal Investigator: Tariq Salam, MD Tacoma General Hospital
Principal Investigator: Hanscy Seide, MD Halifax Medical Center
Principal Investigator: Shalin Shah, MD Largo Medical Center
Principal Investigator: Jonathan Sussman, MD Morristown Medical Center
Principal Investigator: Vijendra Swarup, MD Arizona Heart Hospital
Principal Investigator: Gery Tomassoni, MD Central Baptist Hospital
Principal Investigator: Andy Tran, MD Scottsdale Healthcare
Principal Investigator: Pierce Vatterott, MD United Heart and Vascular Clinic
Principal Investigator: H. James Wang, MD Florida Hospital Memorial Medical Center
Principal Investigator: Darryl Wells, MD Swedish Medical Center
Principal Investigator: Patrick Whalen, MD Vanderbilt University
Principal Investigator: Alan Wimmer, MD St Luke's Hospital
  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
Last Updated: October 23, 2014
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 November 27, 2014