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Completed

NCT Number: NCT01639495

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

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About this study

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have had at least 3 atrial fibrillation episodes within 6 months of this study
  • Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
  • 18 years of age or older

Exclusion criteria

including, but not limited to:

  • Have had previous ablation for atrial fibrillation
  • Have take amiodarone within 6 months of this study
  • Have had any heart surgery within the last 60 days
  • Have had a heart attack within the last 60 days
  • Females who are pregnant or breast feeding

Treatment and study plan

THERMOCOOL® SMARTTOUCH™ Catheter

Device

AF Ablation

Primary outcomes

  1. Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias

    Time frame: Day 91-361

    Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures

  2. Incidence of Primary Adverse Events Within Specified Study Period

    Time frame: 12 months post procedure

    Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.

Secondary outcomes

  1. Peri-procedural Serious Adverse Events

    Time frame: Within 8-30 days post procedure

    Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure

  2. Percentage of Subjects Achieved Acute Effectiveness

    Time frame: 5 hours of procedure time

    Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins

  3. Late Onset Serious Adverse Events

    Time frame: From 31 days post procedure to month 12

    Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2012
Registry last updated
May 15, 2018

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

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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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