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Completed

NCT Number: NCT01716663

CARTO® 3 System and Real Time Intracardiac Ultrasound

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Paroxysmal AF Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Heart Rhythm Research Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter ablation

Device

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

Primary outcomes

  1. Total Fluoroscopy Time

    Time frame: Day 0

    The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.

Secondary outcomes

  1. Total Procedure Time

    Time frame: Day 0

    The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.

  2. Acute Procedural Success

    Time frame: Day 0

    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.

  3. Mean Number of Radiofrequency (RF) Applications

    Time frame: Day 0

    RF application is defined as the number of times RF energy is delivered during the procedure.

  4. Total Radiofrequency (RF) Time

    Time frame: Day 0

    Total RF time is defined as the total time RF is delivered during the procedure.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

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

Acronym: IUAF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Dec 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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