Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)
Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)
Barts & The London NHS Trust
208 participants
Jul 26, 2024
INTERVENTIONAL
Conditions
Summary
The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with catheter ablation for persistent atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure.
Eligibility
Inclusion Criteria4
- Ability to give informed consent
- Age 18-85 years
- Persistent AF (atrial fibrillation lasting \> 7days) of total continuous duration \<2 years as documented in medical notes.
- Patients being considered for cardioversion.
Exclusion Criteria7
- Creatinine clearance (eGFR) \< 30mls/min
- Contraindication or unable to take anticoagulation
- Uncontrolled hypertension
- Contraindication for catheter ablation
- BMI \> 40
- Patients in Persistent AF who have had more than one previous cardioversion.
- Established diagnosis of Hypertrophic cardiomyopathy
Interventions
The catheter ablation (with a CE \[Conformité Européenne\] marked device) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential ablation around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at least a week before the randomisation. The device will provide a continuous recording of the heart rhythm and rate, and will be able to download duration of AF episodes via a home monitoring system to establish the primary endpoint of the study .
Two femoral sheaths (7Fr) will be inserted using ultrasound guidance under local anaesthetic.
Locations(1)
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NCT06096246