CARTO® 3 System and Real Time Intracardiac Ultrasound (IUAF)

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

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Paroxysmal AF
• Intervention / Treatment: Device: Catheter Ablation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 234

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • AZ Heart Rhythm Research Center
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare Research Institute
  • California
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Jacksonville, Florida, United States, 33204
      • East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.
    • Kissimmee, Florida, United States, 34741
      • Osceola Regional Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
    • Tampa, Florida, United States, 33613
      • Pepin Heart Hospital
  • Georgia
    • Gainsville, Georgia, United States, 30501
      • Northeast Georgia Heart Center, PC
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Provena St. Joseph Medical Center
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital CCVR
  • Michigan
    • Saginaw, Michigan, United States, 48601
      • Michigan Cardiovascular Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Pennsylvania
    • Newtown, Pennsylvania, United States, 18940
      • St. Mary Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Heart Institute
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
    • San Antonio, Texas, United States, 78217
      • Northeast Baptist Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: Catheter Ablation; These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.	Device: Catheter Ablation; NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module); Other Names: CARTO® 3 System and Real Time Intracardiac Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Mean Number of Radiofrequency (RF) Applications	RF application is defined as the number of times RF energy is delivered during the procedure.	Day 0
Total Radiofrequency (RF) Time	Total RF time is defined as the total time RF is delivered during the procedure.	Day 0

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Principal Investigator: Usman Siddiqui, MD, Osceola Regional Medical Center; Principal Investigator: Mathew Hutchinson, MD, University of Pennsylvania; Principal Investigator: Andy Tran, MD, Scottsdale Healthcare Research; Principal Investigator: Saumil Oza, MD, East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.; Principal Investigator: Vijendra Swarup, MD, AZ Heart Rhythm Research Center; Principal Investigator: Mohit Rastogi, MD, Washington Adventist Hospital CCVR; Principal Investigator: Brett Gidney, MD, Santa Barbara Cottage Hospital; Principal Investigator: John Scherschel, MD, University of Nebraska; Principal Investigator: Dilip Mathew, MD, Pepin Heart Hospital; Principal Investigator: William Sauer, MD, University of Colorado, Denver; Principal Investigator: Marcie Berger, MD, Medical College of Wisconsin; Principal Investigator: Khawaja Baig, MD, Kettering Medical Center; Principal Investigator: Farhat Khairallah, MD, Tallahassee Research Institute; Principal Investigator: David Fitzgerald, MD, Scott & White Memorial Hospital; Principal Investigator: Gopi Dandamudi, MD, Geisinger Heart Institute; Principal Investigator: Ahmad Abdul-Karim, MD, Provena St. Joseph Medical Center; Principal Investigator: Douglas Esberg, MD, Main Line Health; Principal Investigator: Scott Burke, MD, St. Mary Medical Center; Principal Investigator: Gregory Jones, MD, Wellmont CVA Heart Institute; Principal Investigator: Tapan Rami, MD, The Methodist Hospital Research Institute; Principal Investigator: Salem Sayar, MD, Northeast Georgia Heart Center, PC; Principal Investigator: Gunjan Shukla, MD, Hackensack Meridian Health; Principal Investigator: Philip Gentlesk, MD, Sentara Norfolk General Hospital; Principal Investigator: Asim Yunus, MD, Michigan Cardiovascular Institute; Principal Investigator: Scott Reich, MD, Northeast Baptist Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): December 1, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Observational; Ablation; Symptomatic paroxysmal; Acute procedural outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IUAF