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Completed

NCT Number: NCT01585961

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research, LLC, Huntsville, Alabama, United States

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About this study

This study is to measure the "real-world" acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
  • Age 18 years or older
  • Patients must be able and willing to provide written informed consent to participate in the study

Exclusion criteria

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous ablation for atrial fibrillation
  • Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
  • Uncontrolled heart failure, or NYHA Class III or IV heart failure
  • Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
  • Contraindication to anticoagulation
  • Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
  • Awaiting cardiac transplantation
  • Heart disease in which corrective surgery is anticipated within 6 months
  • Enrollment in investigational drug, biologic or device study
  • Subjects unwilling to comply with protocol or follow-up requirements
  • Patients who are pregnant

Treatment and study plan

Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)

Device

Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.

Primary outcomes

  1. Total Fluoroscopy Time

    Time frame: Day 0 (procedure)

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

  2. Total Procedure Time

    Time frame: Day 0 (procedure)

  3. Acute Procedural Success

    Time frame: Day 0 (procedure)

    Confirmation of entrance and/or exit block across all targeted pulmonary veins.

Secondary outcomes

  1. Mean Number of Radiofrequency (RF) Applications

    Time frame: Day 0 (procedure)

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

  2. Total Radiofrequency (RF) Time

    Time frame: Day 0 (procedure)

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

  3. Fluid Volume Delivered Via Ablation Catheter

    Time frame: Day 0 (procedure)

  4. Number of Patients With Repeat Ablations

    Time frame: 1 year

  5. Post-procedure AF Symptoms

    Time frame: 12 Month Visit

    Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit

  6. Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit

    Time frame: 12 Month Visit

  7. Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation

    Time frame: 12 Month Visit

  8. Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation

    Time frame: 12 Month Visit

  9. Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score

    Time frame: Screening to 12 Month Visit

    Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

Acronym: SFAF

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2012
Registry last updated
Jan 26, 2015

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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