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.
Recommended Actions
- Design a randomized controlled trial unless strong justification exists for alternative design
- Develop clear inclusion/exclusion criteria based on guidance suggestions
- Establish primary effectiveness endpoint (chronic or acute success based on device characteristics)
- Define composite safety endpoint including all required adverse events
- Create standardized monitoring protocol with specified follow-up schedule
- Develop anticoagulation protocol aligned with guidance recommendations
- Select qualified investigators with appropriate training
- Establish comprehensive study monitoring plan
- Design focused data collection forms
- Pre-specify all statistical analyses and sample size calculations
- 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
- Anticoagulation requirements:
- 3-4 weeks therapeutic anticoagulation pre-procedure if patient in atrial flutter
- 3-4 weeks post-procedure anticoagulation for patients in atrial flutter
- Investigator selection based on training and clinical experience
- Comprehensive monitoring plan required
- Statistical considerations must be pre-specified in protocol
Relevant Guidances
- Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- Design Considerations for Medical Device Pivotal Clinical Studies
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- IDE Clinical Investigation Decision Process and Requirements
Related references and norms
- 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.