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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: October 8, 2014
Last verified: October 2014

October 19, 2012
October 8, 2014
October 2012
September 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01716663 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
CARTO® 3 System and Real Time Intracardiac Ultrasound
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).

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Atrial Fibrillation
  • Paroxysmal AF
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
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.
Intervention: Device: Catheter Ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
August 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01716663
IUAF
No
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Principal Investigator: Vijendra Swarup, MD AZ Heart Rhythm Center
Biosense Webster, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP