CARTO® 3 System and Real Time Intracardiac Ultrasound

Atrial Fibrillation Clinical Trial

— IUAF  

Official title:

CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716663
• Other study ID #: IUAF
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: November 24, 2014
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• 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, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Description:

This study is purposed to measure "real world" acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Drug refractory, recurrent symptomatic paroxysmal AF

• Age 18 years or older

• Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

Exclusion Criteria:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause

• Previous ablation for atrial fibrillation

• AF episodes that last longer than 30 days

• Uncontrolled heart failure, or NYHA Class III or IV heart failure

• Documented intra-atrial thrombus or other abnormality on pre-ablation imaging

• Contraindication to anticoagulation

• Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months

• Awaiting cardiac transplantation

• Heart disease for which corrective surgery is anticipated within 6 months

• Enrollment in other investigational drug or device study

• Subjects unwilling to comply with protocol or follow-up requirements

• Patients who are pregnant

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal AF

Intervention

Device:
• Catheter Ablation
NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Locations

Country	Name	City	State
United States	JFK Medical Center	Atlantis	Florida
United States	University of Colorado Denver	Aurora	Colorado
United States	Northeast Georgia Heart Center, PC	Gainsville	Georgia
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.	Jacksonville	Florida
United States	Provena St. Joseph Medical Center	Joliet	Illinois
United States	Kettering Medical Center	Kettering	Ohio
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	St. Mary Medical Center	Newtown	Pennsylvania
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	AZ Heart Rhythm Research Center	Phoenix	Arizona
United States	Michigan CardioVascular Institute	Saginaw	Michigan
United States	Northeast Baptist Hospital	San Antonio	Texas
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Scottsdale Healthcare Research Institute	Scottsdale	Arizona
United States	Washington Adventist Hospital CCVR	Takoma Park	Maryland
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Pepin Heart Hospital	Tampa	Florida
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Geisinger Heart Institute	Wilkes-Barre	Pennsylvania
United States	Lankenau Institute for Medical Research	Wynnewood	Pennsylvania

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.	Day 0	No
Secondary	Total Procedure Time	The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.	Day 0	No
Secondary	Acute Procedural Success	Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.	Day 0	No
Secondary	Mean Number of Radiofrequency (RF) Applications	RF application is defined as the number of times RF energy is delivered during the procedure.	Day 0	No
Secondary	Total Radiofrequency (RF) Time	Total RF time is defined as the total time RF is delivered during the procedure.	Day 0	No