1 Background
2 Methods
2.1 Primary endpoint and hypothesis
2.2 Secondary endpoints
2.3 Safety analysis
Air embolism | |
Atrio-oesophageal perforation or fistula | |
Atrio-septal defect | |
Atrioventricular node damage | |
Bleedings events, including groin haematoma | |
Cardiac or coronary artery perforation | |
Death | |
Dysphagia | |
Major vascular complication | |
Myocardial infarction | |
Need for unplanned cardiac or vascular surgery | |
Pericardial effusion | |
Pericarditis | |
Persistent or sustained cardiac arrhythmia | |
Phrenic nerve paralysis | |
Pulmonary vein stenosis | |
Site infection from loop recorder insertion | |
Stroke or transient ischaemic attack |
2.4 Study design
-
‘Conventional’ treatment with radiofrequency CTI ablation, OR
-
‘Novel’ treatment with cryoballoon PVI
2.5 Participants
2.6 Interventions
2.6.1 Radiofrequency CTI ablation
2.6.2 Cryoballoon PVI
-
Time to PVI < 60 s if PV signals are discernible on any pole(s) of the Achieve Advance Mapping catheter, OR
-
If PV signals not discernible on any pole(s) of the Achieve Advance Mapping catheter, lowering of balloon temperature below − 40 °C at 60 s
2.6.3 Implantable loop recorder
Parameter | Settings |
---|---|
Reason for monitoring | Suspected AF |
Detection | |
Tachy | On |
Interval rate | 146 bpm |
Duration | 12 beats |
Brady | On |
Interval rate | 30 bpm |
Duration | 4 beats |
Pauses | On |
Duration | 3 s |
AT/AF detection | AF only |
Sensitivity | Less sensitive (nominal) |
Ectopy rejection | Nominal |
AT/AF recording threshold | All episodes |
2.7 Follow-up
2.8 Sample size calculation
2.9 Funding and sponsorship
3 Discussion
Study | n | Ablation strategy | Cardiac monitoring | Follow-up period | Incidence of atrial arrhythmias |
---|---|---|---|---|---|
Navarette [6] | 48 | CTI vs CTI + PVI | 48-h Holter | 16 months | 56% vs 13% |
PReVENT AF [7] | 50 | CTI vs CTI + PVI | ILR | 12 months | 52% vs 12% |
REDUCE AF [8] | 216 | CTI vs CTI + PVI | ILR, event recorder or 7-day Holter | 18 months | 40% vs 29% |
Triple A* [1] | 43 | CTI vs PVI | ILR | 17 months | 61% vs 10% |