Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBarts & The London NHS Trust
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Creatinine clearance (eGFR) < 30mls/min
Contraindication or unable to take anticoagulation
Uncontrolled hypertension
Contraindication for catheter ablation
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary vein isolation
Procedure/SurgeryThe 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
Procedure/SurgeryDC 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.
Implantable loop recorder
DeviceThe 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 .
Femoral sheath insertion
Procedure/SurgeryTwo femoral sheaths (7Fr) will be inserted using ultrasound guidance under local anaesthetic.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Experimental: DCCV + PVIActive comparator 4 interventions
Group B: DC cardioversion (DCCV) + Sham procedureSham comparator 3 interventions
Trial outcomes
Primary outcomes
1
Recurrence of Persistent AF (AF episode lasting > 7 days) or left atrial ablation/ DC Cardioversion for atrial arrhythmia after 6 weeks of blanking period.
Rates of recurrence of arrhythmia and data on episodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system \[ rhythm on ILR ECG\]
Time frame
Within 12 months following the procedure2
A change in the burden of AF, as measured by continuous monitoring through ILR (Implantable loop recorder) at 3 months
Percentage time the patient is in AF as measured by the ILR device (in percentage) compared to pre-randomisation
Time frame
3 months post randomisationSecondary outcomes
1
Death
Death of the patient
Time frame
Within 12 months of study index procedure.2
Rates of Subject Hospital re-admission
Rates of admission of the subject back to hospital following the initial treatment for AF
Time frame
Within 12 months of study index procedure.3
Procedural complications
Assessment of rates of events that are considered procedural complications during the DCCV +/- Pulmonary Vein isolation (PVI) procedure
Time frame
Up to 7 days post procedure4
Bleeding events
Rates of bleeding in subjects following the study DCCV +/- pulmonary vein isolation (PVI) procedures
Time frame
Within 7 days of the index procedureSponsors and contacts
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Source ClinicalTrials.gov