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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01716663
First received: October 19, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Atrial Fibrillation
Paroxysmal AF
Device: Catheter Ablation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Fluoroscopy Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure.


Secondary Outcome Measures:
  • Procedure Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure.

  • Acute Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Acute success will be measured via confirmation of pulmonary vein isolation method.

  • Safety [ Time Frame: Within 7 days of the procedure ] [ Designated as safety issue: Yes ]
    Procedural complications, electrocardiogram abnormalities and adverse events.

  • Number of Radiofrequency (RF) Applications [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    RF application will be measured by number of times delivered during the procedure.

  • Total Radiofrequency (RF) Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Total RF time will be measured for the total time RF is delivered during the procedure.


Enrollment: 234
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: CARTO® 3 System and Real Time Intracardiac Ultrasound

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716663

  Hide Study Locations
Locations
United States, Arizona
AZ Heart Rhythm Center
Phoenix, Arizona, United States, 85006
Clinical Research Advantage, Inc.
Phoenix, Arizona, United States, 85015
United States, California
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Good Samaritan Hospital
San Jose, California, United States, 95124
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
United States, Colorado
Colorado Cardiac Alliance, LLC
Colorado Springs, Colorado, United States, 80907
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
St. Vincent's Ambulatory Care, Inc.
Jacksonville, Florida, United States, 33204
Tallahassee Resesarch Institute, Inc.
Tallahassee, Florida, United States, 32308
Pepin Heart Hospital
Tampa, Florida, United States, 33613
United States, Illinois
Provena Saint Joseph Medical Center
Joliet, Illinois, United States, 60435
United States, Missouri
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63141
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
MediSync Clinical Research
Cincinnati, Ohio, United States, 45212
United States, Pennsylvania
Geisinger Wyoming Valley Medical Center
Danville, Pennsylvania, United States, 17822
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
ARIA Health
Philadelphia, Pennsylvania, United States, 19114
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 17104
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
McKay Dee Hospital
Ogden, Utah, United States, 84403
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Vijendra Swarup, MD AZ Heart Rhythm Center
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01716663     History of Changes
Other Study ID Numbers: IUAF
Study First Received: October 19, 2012
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biosense Webster, Inc.:
Symptomatic paroxysmal
Atrial fibrillation
Observational
Acute procedural outcomes
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014