Atrial FibrillationSFAFNCT01585961
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
An observational study of Atrial Fibrillation and Paroxysmal Arrhythmia, run by Biosense Webster, Inc. at 45 sites in United States.
Trial summary
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Paroxysmal Arrhythmia
- What is being tested?
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Type of treatment
- Medical device
- How many people
- 511 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2012to Jul 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Alaska Heart Institute, LLC
Anchorage, Alaska, 99508
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
JFK Medical Center
Atlantis, Florida, 33462
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, 70808
University of Chicago Medical Center
Chicago, Illinois, 60637
Bethesda North Hospital
Cincinnati, Ohio, 45242
University of Cincinnati
Cincinnati, Ohio, 45267
Riverside Methodist Hospital
Columbus, Ohio, 43214
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117
Central Bucks Specialists, LTD
Doylestown, Pennsylvania, 18901
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Lutheran Medical Group, LLC
Fort Wayne, Indiana, 46804
Baylor All Saints Medical Center
Fort Worth, Texas, 76104
Plaza Medical Center
Grapevine, Texas, 76501
Bellin Memorial Hospital, Inc.
Green Bay, Wisconsin, 54301
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030
Heart Center Research, LLC
Huntsville, Alabama, 35801
University of Iowa Hospital & Clinics
Iowa City, Iowa, 55242
St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, 32204
University of Kansas Hospitals
Kansas City, Kansas, 66160
St. Luke's Mid American Heart Institute
Kansas City, Missouri, 64111
Scripps Clinical Research
La Jolla, California, 92037
Largo Medical Center
Largo, Florida, 33774
Central Baptist Hospital
Lexington, Kentucky, 40503
Bryan LGH Heart Institute
Lincoln, Nebraska, 68506
Baptist Hospital
Louisville, Kentucky, 40207
North Shore University Hospital
Manhasset, New York, 11030
Morristown Medical Center
Morristown, New Jersey, 07960
Centennial Heart
Nashville, Tennessee, 37203
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232-8802
New York Presbyterian Hospital, Columbia University Medical Center
New York, New York, 10032
The Cardiac Center of Creighton University
Omaha, Nebraska, 68131
Florida Hospital - Orlando
Orlando, Florida, 32803
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Arizona Heart Hospital
Phoenix, Arizona, 85006
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102
San Diego Cardiac Center
San Diego, California, 92123
UCSF Medical Center
San Francisco, California, 94143
Cardiology Associates of Savannah
Savannah, Georgia, 31419
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Cardiac Study Center
Tacoma, Washington, 98405
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Tampa General Hospital
Tampa, Florida, 33606
Genesis Healthcare Systems
Zanesville, Ohio, 43701
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Paroxysmal Arrhythmia
- Being tested
- Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)
- Keywords
- Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation, Drug refractory, Arrhythmia Recurrent, Symptomatic
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (procedure)
Total Procedure Time
Measured: Day 0 (procedure)
Acute Procedural Success
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
Measured: Day 0 (procedure)
Secondary outcomes (9)
Mean Number of Radiofrequency (RF) Applications
RF applications is defined as the number of times RF energy is delivered during the procedure.
Measured: Day 0 (procedure)
Total Radiofrequency (RF) Time
Total RF time is defined as the total time that RF energy is delivered during the procedure.
Measured: Day 0 (procedure)
Fluid Volume Delivered Via Ablation Catheter
Measured: Day 0 (procedure)
Number of Patients With Repeat Ablations
Measured: 1 year
Post-procedure AF Symptoms
Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit
Measured: 12 Month Visit
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
Measured: 12 Month Visit
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
Measured: 12 Month Visit
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
Measured: 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.
Measured: Screening to 12 Month Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gery Tomassoni, MD, Principal investigator, Central Baptist HospitalScott Pollak, MD, Principal investigator, Florida Hospital - OrlandoAndy Tran, MD, Principal investigator, Scottsdale Healthcare Research InstituteSaumil Oza, MD, Principal investigator, St. Vincent's Ambulatory Care, Inc.Steven Compton, MD, Principal investigator, Alaska Heart Institute, LLCAnshul Patel, MD, Principal investigator, St. Joseph's Hospital of AtlantaRobert Fishel, MD, Principal investigator, JFK Medical CenterKenneth Civello, MD, Principal investigator, Cardiovascular Research Foundation of Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585961
- Sponsor's protocol ID
- ThermoCool SF Phase IV
- Acronym
- SFAF
- Status last verified
- Jan 2015
- First submitted
- 14 Mar 2012
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population
- ClinicalTrials.gov ID
- NCT01585961
- Acronym / sponsor ID
- SFAF / ThermoCool SF Phase IV
- Conditions
- Atrial Fibrillation, Paroxysmal Arrhythmia
- Keywords
- Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation, Drug refractory, Arrhythmia Recurrent, Symptomatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | – | Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Catheter Ablation |
Primary outcome
Total Fluoroscopy Time
Time frame: Day 0 (procedure)
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)
Acute Procedural Success
Time frame: Day 0 (procedure)
Confirmation of entrance and/or exit block across all targeted pulmonary veins.
9 secondary outcomes
Mean Number of Radiofrequency (RF) Applications
Time frame: Day 0 (procedure)
Total Radiofrequency (RF) Time
Time frame: Day 0 (procedure)
Fluid Volume Delivered Via Ablation Catheter
Time frame: Day 0 (procedure)
Number of Patients With Repeat Ablations
Time frame: 1 year
Post-procedure AF Symptoms
Time frame: 12 Month Visit
Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
Time frame: 12 Month Visit
Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
Time frame: 12 Month Visit
Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
Time frame: 12 Month Visit
Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Time frame: Screening to 12 Month Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gery Tomassoni, MD principal investigator
Central Baptist Hospital
Scott Pollak, MD principal investigator
Florida Hospital - Orlando
Andy Tran, MD principal investigator
Scottsdale Healthcare Research Institute
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Paroxysmal Arrhythmia, run by Biosense Webster, Inc. at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fluoroscopy Time (time frame: Day 0 (procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015; AzTrials last refreshed its copy on 28 Oct 2026.