NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

Atrial Fibrillation Clinical Trial

— SFAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585961
• Other study ID #: ThermoCool SF Phase IV
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2012
• Last updated: January 20, 2015
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
United States	Alaska Heart Institute, LLC	Anchorage	Alaska
United States	St. Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Florida Hospital Memorial Medical Center	Daytona Beach	Florida
United States	Central Bucks Specialists, LTD	Doylestown	Pennsylvania
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Lutheran Medical Group, LLC	Fort Wayne	Indiana
United States	Baylor All Saints Medical Center	Fort Worth	Texas
United States	Plaza Medical Center	Grapevine	Texas
United States	Bellin Memorial Hospital, Inc.	Green Bay	Wisconsin
United States	Texas Heart Institute at St. Luke's Episcopal Hospital	Houston	Texas
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	University of Iowa Hospital & Clinics	Iowa City	Iowa
United States	St. Vincent's Ambulatory Care, Inc.	Jacksonville	Florida
United States	St. Luke's Mid American Heart Institute	Kansas City	Missouri
United States	University of Kansas Hospitals	Kansas City	Kansas
United States	Scripps Clinical Research	La Jolla	California
United States	Largo Medical Center	Largo	Florida
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Baptist Hospital	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Morristown Medical Center	Morristown	New Jersey
United States	Centennial Heart	Nashville	Tennessee
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee
United States	New York Presbyterian Hospital, Columbia University Medical Center	New York	New York
United States	The Cardiac Center of Creighton University	Omaha	Nebraska
United States	Florida Hospital - Orlando	Orlando	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Arizona Heart Hospital	Phoenix	Arizona
United States	San Diego Cardiac Center	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	Cardiology Associates of Savannah	Savannah	Georgia
United States	Scottsdale Healthcare Research Institute	Scottsdale	Arizona
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	United Heart and Vascular Clinic	St. Paul	Minnesota
United States	Cardiac Study Center	Tacoma	Washington
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tampa General Hospital	Tampa	Florida
United States	Genesis Healthcare Systems	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Total Procedure Time		Day 0 (procedure)	Yes
Primary	Acute Procedural Success	Confirmation of entrance and/or exit block across all targeted pulmonary veins.	Day 0 (procedure)	No
Secondary	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)	No
Secondary	Total Radiofrequency (RF) Time	Total RF time is defined as the total time that RF energy is delivered during the procedure.	Day 0 (procedure)	No
Secondary	Fluid Volume Delivered Via Ablation Catheter		Day 0 (procedure)	No
Secondary	Number of Patients With Repeat Ablations		1 year	No
Secondary	Post-procedure AF Symptoms	Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit	12 Month Visit	No
Secondary	Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit		12 Month Visit	No
Secondary	Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation		12 Month Visit	No
Secondary	Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation		12 Month Visit	No
Secondary	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	No