Table 2 Open in new tab Upcoming...

Trial

Target enrolment

Enrolment criteria

Treatment groups

Primary outcome

Follow-up

OCEAN (NCT02168829)

1572

Non-valvular AF
CHA₂DS₂VASc score ≥ 1
≥1 year post-successful AF catheter ablation without clinically apparent arrhythmia recurrence on serial 24-h Holter or an ECG monitoring

1. Rivaroxaban 15 mg daily

2. ASA 75–160 mg daily

Composite of stroke, systemic embolism, and covert embolic stroke on cerebral MRI

36 months

ODIn-AF (NCT02067182)

630

Non-valvular symptomatic, paroxysmal or persistent AF
CHA₂DS₂VASc score ≥ 2
Undergoing circumferential antral pulmonary vein ablation
Sinus rhythm (on 72-h Holter) following 3 months blanking period and 3 months observation period after ablation procedure
No clinical evidence of recurrent AF following 3 months blanking period and 3 months assessed by symptoms
No contraindications for OAC assessed by randomization of MRI of the brain

1. Dabigatran 150 mg b.i.d. (or 110 mg b.i.d. if age ≥ 75 years, CrCl 30–50 mL/min, concomitant verapamil use, increased bleeding risk)

2. No anticoagulation

New micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging at 12 months compared to baseline MRI (3 months after AF catheter ablation)

12 months

OPTION (NCT03795298)

1600

Non-valvular AF
Catheter ablation between 90 and 180 days prior to randomization (or planning on catheter ablation within 10 days of randomization)
Able to undergo serial transoesophageal echocardiography

1. Left atrial appendage occlusion (WATCHMAN FLX)

2. Oral anticoagulation

1. Composite stroke, systemic embolism, and all-cause death

2. Non-procedural bleeding

36 months

Table 2

Open in new tab

Upcoming randomized control trials assessment OAC strategies following catheter ablation of atrial fibrillation

Trial	Target enrolment	Enrolment criteria	Treatment groups	Primary outcome	Follow-up
OCEAN (NCT02168829)	1572	Non-valvular AF CHA₂DS₂VASc score ≥ 1 ≥1 year post-successful AF catheter ablation without clinically apparent arrhythmia recurrence on serial 24-h Holter or an ECG monitoring	1. Rivaroxaban 15 mg daily 2. ASA 75–160 mg daily	Composite of stroke, systemic embolism, and covert embolic stroke on cerebral MRI	36 months
ODIn-AF (NCT02067182)	630	Non-valvular symptomatic, paroxysmal or persistent AF CHA₂DS₂VASc score ≥ 2 Undergoing circumferential antral pulmonary vein ablation Sinus rhythm (on 72-h Holter) following 3 months blanking period and 3 months observation period after ablation procedure No clinical evidence of recurrent AF following 3 months blanking period and 3 months assessed by symptoms No contraindications for OAC assessed by randomization of MRI of the brain	1. Dabigatran 150 mg b.i.d. (or 110 mg b.i.d. if age ≥ 75 years, CrCl 30–50 mL/min, concomitant verapamil use, increased bleeding risk) 2. No anticoagulation	New micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging at 12 months compared to baseline MRI (3 months after AF catheter ablation)	12 months
OPTION (NCT03795298)	1600	Non-valvular AF Catheter ablation between 90 and 180 days prior to randomization (or planning on catheter ablation within 10 days of randomization) Able to undergo serial transoesophageal echocardiography	1. Left atrial appendage occlusion (WATCHMAN FLX) 2. Oral anticoagulation	1. Composite stroke, systemic embolism, and all-cause death 2. Non-procedural bleeding	36 months

Trial

Target enrolment

Enrolment criteria

Treatment groups

Primary outcome

Follow-up

OCEAN (NCT02168829)

1572

Non-valvular AF
CHA₂DS₂VASc score ≥ 1
≥1 year post-successful AF catheter ablation without clinically apparent arrhythmia recurrence on serial 24-h Holter or an ECG monitoring

1. Rivaroxaban 15 mg daily

2. ASA 75–160 mg daily

Composite of stroke, systemic embolism, and covert embolic stroke on cerebral MRI

36 months

ODIn-AF (NCT02067182)

630

Non-valvular symptomatic, paroxysmal or persistent AF
CHA₂DS₂VASc score ≥ 2
Undergoing circumferential antral pulmonary vein ablation
Sinus rhythm (on 72-h Holter) following 3 months blanking period and 3 months observation period after ablation procedure
No clinical evidence of recurrent AF following 3 months blanking period and 3 months assessed by symptoms
No contraindications for OAC assessed by randomization of MRI of the brain

1. Dabigatran 150 mg b.i.d. (or 110 mg b.i.d. if age ≥ 75 years, CrCl 30–50 mL/min, concomitant verapamil use, increased bleeding risk)

2. No anticoagulation

New micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging at 12 months compared to baseline MRI (3 months after AF catheter ablation)

12 months

OPTION (NCT03795298)

1600

Non-valvular AF
Catheter ablation between 90 and 180 days prior to randomization (or planning on catheter ablation within 10 days of randomization)
Able to undergo serial transoesophageal echocardiography

1. Left atrial appendage occlusion (WATCHMAN FLX)

2. Oral anticoagulation

1. Composite stroke, systemic embolism, and all-cause death

2. Non-procedural bleeding

36 months

AF, atrial fibrillation; CrCl, creatinine clearance; ECG, electrocardiogram; MRI, magnetic resonance imaging; OAC, oral anticoagulation; OCEAN, Optimal Anti-Coagulation for Enhanced-Risk Patients Post-Catheter Ablation for Atrial Fibrillation; ODIn-AF, Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After PVI for Atrial Fibrillation; OPTION, Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation.

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