2. Selection Criteria
Inclusion Exclusion
- Participants from USA, EU, Australia (2008 –
2016)
- Symptomatic atrial fibrillation
- Failure or intolerance to anti-arrhythmics
- LVEF ≤ 35%
- NYHA class ≥ II
- ICD/CRTD with Home Monitoring capabilities
implanted
- Previous left heart ablation procedure for AF
- Contraindication to chronic anticoagulation
therapy
- Documented left atrial diameter >6 cm
- ACS or CVA within 2 months
- Planned cardiovascular intervention
- Listed for heart transplant
- Cardiac assist device implanted
- Life expectancy ≤ 12 months
- Uncontrolled hypertension
- Untreated thyroid disease
- Dialysis
- Mental or physical disability
- Pregnant or actively breast feeding
7. • Failure of Blinding
• Post-randomization exclusions
• Inadequate search for toxicity
What’s wrong with this study?
8. Question Score
1. Were they really randomized? 0.8
2. Are the patients similar to our own? 0.8
3. Are the results both statistically and clinically
significant?
1.0
4. Is the maneuver feasible? 0.7
5. Are all relevant outcomes reported? 0.5
6. Were all entered patients accounted for at the
conclusion?
0.7
What would David Sackett Say?
Total = 4.5 / 6.0 = 75%