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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01716663
First received: October 19, 2012
Last updated: November 24, 2014
Last verified: November 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:
  • Total 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 and summed to derive the total.


Secondary Outcome Measures:
  • Total 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 and summed to derive the total.

  • Acute Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.

  • Mean Number of Radiofrequency (RF) Applications [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    RF application is defined as the number of times RF energy is delivered during the procedure.

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


Enrollment: 234
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: September 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

  Show 26 Study Locations
Sponsors and Collaborators
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: Robert Fishel, MD JFK Medical Center
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 University Medical Center
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
  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
Results First Received: November 24, 2014
Last Updated: November 24, 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2015