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Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization

This guidance addresses clinical study design for surgical ablation devices intended for the treatment of atrial fibrillation (AF) under direct visualization. It applies to new surgical ablation devices and legally marketed devices seeking a new AF treatment indication. The guidance specifically excludes cardiac ablation devices not used under direct visualization and those delivered intravascularly.

  1. Design a randomized controlled trial with 12-month follow-up period
  2. Develop detailed protocols for:
    • Patient selection criteria
    • Anticoagulation management
    • Follow-up visits and monitoring
    • Adverse event reporting
  3. Establish an independent Clinical Events Committee
  4. Create investigator training program
  5. Implement standardized neurological assessments
  6. Define clear primary effectiveness and safety endpoints
  7. Develop statistical analysis plan including sample size justification
  8. Create detailed documentation procedures for all study aspects
  9. Establish quality monitoring procedures
  10. Plan for potential post-approval studies with extended follow-up

Key Considerations

Clinical testing

  • Randomized controlled trials (RCTs) are recommended as the least burdensome means to develop valid scientific evidence
  • 12-month minimum follow-up period required
  • Primary effectiveness endpoint should be freedom from AF/AFL/AT for one year without Class I or III antiarrhythmic drugs
  • Separate studies recommended for different types of AF (paroxysmal vs persistent)
  • Standardized follow-up visits at 30 days, 3, 6, 9 and 12 months

Human Factors

  • Investigator selection should be based on qualification and experience
  • Training required for investigators lacking thorough knowledge of procedures
  • Consider including “roll-in” subjects to avoid learning curve bias

Labelling

  • Should identify factors affecting benefit/risk profile:
    • Type of AF treated
    • Surgical approach used
    • Concomitant procedures
    • Relevant patient characteristics

Safety

  • Primary safety composite endpoint including:
    • All-cause death
    • Stroke and TIA
    • Myocardial infarction
    • Thromboembolic events
    • Excessive bleeding
    • Deep sternal wound infection
    • Damage to conduction system requiring pacemaker
    • Damage to peripheral structures
    • Pulmonary vein stenosis
  • Neurological assessment required before and after procedure
  • One year safety follow-up recommended

Other considerations

  • NIH Stroke Scale (NIHSS): Standardized scale for assessment of neurologic deficit
  • Modified Rankin Score (MRS): Scale for assessment of stroke disability

Original guidance

  • Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
  • HTML / PDF
  • Issue date: 2013-02-14
  • Last changed date: 2020-02-28
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: abc6ff19d49e89d52c23e583b5838d08
This post is licensed under CC BY 4.0 by the author.