Clinical trial NCT01585961: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
Official title: NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Paroxysmal Arrhythmia
Keywords: Symptomatic paroxysmal
Atrial fibrillation
Observational
Acute procedural outcomes
Ablation
Drug refractory
Arrhythmia Recurrent
Symptomatic
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older and younger patients with drug refractory, symptomatic paroxysmal atrial fibrillation.

Brief 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.

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 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

Primary outcomes:
measure: Total Fluoroscopy Time
timeFrame: Day 0 (procedure)
measure: Total Procedure Time
timeFrame: Day 0 (procedure)
measure: Acute Procedural Success
timeFrame: Day 0 (procedure)
Secondary outcomes:
measure: Mean Number of Radiofrequency (RF) Applications
timeFrame: Day 0 (procedure)
measure: Total Radiofrequency (RF) Time
timeFrame: Day 0 (procedure)
measure: Fluid Volume Delivered Via Ablation Catheter
timeFrame: Day 0 (procedure)
measure: Number of Patients With Repeat Ablations
timeFrame: 1 year
measure: Post-procedure AF Symptoms
timeFrame: 12 Month Visit
measure: Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit
timeFrame: 12 Month Visit
measure: Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation
timeFrame: 12 Month Visit
measure: Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation
timeFrame: 12 Month Visit
measure: Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
timeFrame: Screening to 12 Month Visit
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart Institute, LLC
state: Alaska
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Research Institute
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Daytona Beach
country: United States
facility: Florida Hospital Memorial Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Ambulatory Care, Inc.
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital - Orlando
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Savannah
country: United States
facility: Cardiology Associates of Savannah
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Medical Group, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospitals
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Baptist Hospital
state: Kentucky
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: St. Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Mid American Heart Institute
state: Missouri
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: The Cardiac Center of Creighton University
state: Nebraska
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital, Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare Systems
state: Ohio
city: Doylestown
country: United States
facility: Central Bucks Specialists, LTD
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor All Saints Medical Center
state: Texas
city: Grapevine
country: United States
facility: Plaza Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute at St. Luke's Episcopal Hospital
state: Texas
city: Tacoma
country: United States
facility: Cardiac Study Center
state: Washington
city: Green Bay
country: United States
facility: Bellin Memorial Hospital, Inc.
state: Wisconsin
Study officials:
affiliation: Central Baptist Hospital
name: Gery Tomassoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Hospital - Orlando
name: Scott Pollak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scottsdale Healthcare Research Institute
name: Andy Tran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Vincent's Ambulatory Care, Inc.
name: Saumil Oza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alaska Heart Institute, LLC
name: Steven Compton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital of Atlanta
name: Anshul Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK Medical Center
name: Robert Fishel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Research Foundation of Louisiana
name: Kenneth Civello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bethesda North Hospital
name: Gaurang Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Alexandru Costea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riverside Methodist Hospital
name: Sreedhar Billakanty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Hospital Memorial Medical Center
name: H. James Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Bucks Specialists, Ltd.
name: John Harding, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexian Brothers Medical Center
name: Mohammed Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor All Saints Medical Center
name: Vijay Jayachandran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lutheran Medical Group, LLC
name: Sree Karanam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Plaza Medical Center
name: M. Craig Delaughter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bellin Memorial Hospital, Inc.
name: Mohammad Jazayeri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Institute at St. Luke's Episcopal Hospital
name: Abdi Rasekh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Research, LLC
name: Scott Allison, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Hospital & Clinics
name: Alexander Mazur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Hospitals
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Hospital Mid American Heart Institute
name: Alan Wimmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Clinical Research
name: Ali Hamzei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Largo Medical Center
name: Shalin Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bryan LGH Heart Institute
name: Michael Kutayli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Hospital
name: John Mandrola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Shore University Hospital
name: Stuart Beldner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Joshua Moss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centennial Heart
name: Greg Bashian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Heart and Vascular Institute
name: Patrick Whalen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital, Columbia University Medical Center
name: Angelo Biviano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cardiac Center of Creighton University
name: Hussam Abuissa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein Medical Center
name: Sumeet Mainigi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego Cardiac Center
name: Charles Athill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSF Medical Center
name: Edward Gerstenfeld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Associates of Savannah
name: Michael Chisner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Hospital
name: Vijendra Swarup, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prairie Education and Research Cooperative
name: Ziad Issa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac Study Center
name: Tariq Salam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Adventist Hospital
name: Sung Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Genesis Healthcare Systems
name: M. Magdy Migeed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morristown Medical Center
name: Jonathan Sussman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampa General Hospital
name: Bengt Herweg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: United Heart and Vascular Clinic
name: Pierce Vatterott, MD
role: PRINCIPAL_INVESTIGATOR
References: