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Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter

This guidance addresses clinical study designs for catheter ablation devices specifically intended for the treatment of type I atrial flutter (cavotricuspid dependent, right atrial macro-reentrant arrhythmia). It applies to class III devices requiring PMA approval under product code OAD.

  1. Design a randomized controlled trial unless strong justification exists for alternative design
  2. Develop clear inclusion/exclusion criteria based on guidance suggestions
  3. Establish primary effectiveness endpoint (chronic or acute success based on device characteristics)
  4. Define composite safety endpoint including all required adverse events
  5. Create standardized monitoring protocol with specified follow-up schedule
  6. Develop anticoagulation protocol aligned with guidance recommendations
  7. Select qualified investigators with appropriate training
  8. Establish comprehensive study monitoring plan
  9. Design focused data collection forms
  10. Pre-specify all statistical analyses and sample size calculations
  11. Implement independent clinical events committee for adverse event evaluation

Key Considerations

Clinical testing

  • Randomized Controlled Trials (RCTs) are recommended as the preferred study design
  • Primary effectiveness endpoint should be chronic success (absence of recurrent atrial flutter at 6 months)
  • For select catheters, acute procedural success (bidirectional block at cavo-tricuspid isthmus) may serve as surrogate endpoint
  • Follow-up visits recommended at 7 days, 30 days and 6 months
  • Study subjects should be monitored through symptoms documentation and cardiac rhythm assessment

Safety

  • Composite serious adverse event endpoint required including:
    • Cardiac perforation/tamponade
    • Cerebrovascular accident
    • Complete heart block
    • Death
    • Myocardial infarction
    • Pulmonary embolism
    • Transient ischemic attack
  • Safety assessment period of 7 days post-ablation
  • Independent clinical events committee required for adverse events evaluation

Other considerations

  • 21 CFR 812: Investigational Device Exemptions
  • 21 CFR 56: Institutional Review Boards
  • 21 CFR 50: Protection of Human Subjects
  • 21 CFR 814.15: Research Conducted Outside the United States

Original guidance

  • Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
  • HTML / PDF
  • Issue date: 2008-08-05
  • Last changed date: 2020-03-24
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP)
  • ReguVirta summary file ID: b483bdfb03e6ac3fe9df99a181ccdb35
This post is licensed under CC BY 4.0 by the author.