Clinical Study Design for Cardiac Ablation Systems in Treatment of Ventricular Tachycardia
This guidance provides recommendations for clinical study design to evaluate the safety and effectiveness of cardiac ablation systems for treating Ventricular Tachycardia (VT). It outlines both non-randomized and randomized study design options, focusing on specific considerations for different patient populations (ischemic VT vs. idiopathic VT).
Recommended Actions
- Define study design type (randomized or non-randomized) based on intended claims and patient population
- Establish clear inclusion/exclusion criteria, particularly regarding VT frequency and ICD requirements
- Define primary endpoints including acute success, 6-month success, and complication rates
- Develop detailed protocol for VT episode documentation
- Implement required pre and post-ablation procedures
- Establish statistical analysis plan according to chosen study design
- Create clear criteria for repeat ablations and/or crossovers
- Develop comprehensive adverse event monitoring system
- Establish consistent documentation methods for VT episodes
- Create detailed follow-up schedule and procedures
Key Considerations
Clinical testing
- Two study design options: non-randomized (single-arm) and randomized (concurrent control)
- 6-month follow-up period required
- Primary endpoints must include acute success rate, 6-month success rate, and complication rate
- Pre and post-ablation procedures including echocardiogram and neurologic examination
- VT episode documentation through ICD interrogation, event monitoring, or ECG
- Baseline data collection for 6 months prior to ablation in non-randomized studies
Labelling
- Success criteria and endpoints must be clearly defined
- Consistency in offering repeat ablations should be maintained for labeling purposes
Safety
- Major complications must be documented within the first week post-procedure
- Complications should be stratified between acute (within first week) and later occurrences
- Clear definition of major vs. minor complications provided in guidance
Other considerations
- Patient selection criteria must be clearly defined
- Statistical analysis requirements for both study designs
- Specific considerations for repeat ablations and crossovers
- Different success criteria for ischemic vs. idiopathic VT patients
Original guidance
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