Investigation of Therapeutic Ablation Versus Cardioversion for AF (ORBITA-AF)

Barts & The London NHS Trust

Status: Completed

Conditions: Persistent Atrial Fibrillation; Cardiac Arrhythmia

Treatments: Procedure: Pulmonary vein isolation; Device: Implantable loop recorder; Procedure: DC Cardioversion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03907982

ORBITA-AF Pilot study

Details and patient eligibility

About

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.

Full description

After adequate stroke prevention (e.g. anticoagulation) and rate control, the optimum strategy for patients who continue to be symptomatic with persistent AF has not been established. Cardioversion with antiarrhythmic medication is commonly used as a first-line rhythm control strategy despite very high recurrence rates of the index arrhythmia and high serious complications associated with this strategy. Further treatment options, such as catheter ablation or implantation of a pacemaker and ablation of the atrioventricular (AV) node, are considered once AF recurs. The benefits of first-line ablation in patients presenting with persistent AF has not been tested. We seek to perform a blinded, randomised trial comparing an electrical cardioversion-led strategy with a pulmonary-vein isolation strategy for the treatment of persistent atrial fibrillation.

No blinded randomised controlled trial comparing early-ablation strategies to cardioversion-led strategies has been performed. The rationale for blinding where possible in clinical trials is well established. The recently published ORBITA trial performed a blinded, multicentre randomised trial of percutaneous coronary intervention (PCI) in stable angina compared to a placebo procedure. This trial demonstrated that the efficacy of invasive procedures can be assessed with a placebo procedure and that this type of trial remains necessary. Knowledge of treatment assignment influences physician behaviour, drug recommendations and encourages bias in outcome reporting. The treatment effect size and the effects of confounding factors will be exaggerated and thus limit the interpretation of the true patient experienced outcomes either strategy. In a comparison of surgical procedures, a sham-control arm represents the gold standard of blinding. A systematic review of placebo-controlled surgical trials found no evidence of harm to participants assigned to the placebo group. For a procedure whose primary purpose is to give sustained symptomatic relief, definitive quantification of the true placebo-controlled effect size of AF ablation is necessary. There is a need to clarify the relationship between patient reported symptoms and the arrhythmia itself. Patient reported symptoms may not always be related to the severity of the arrhythmia or quality of life. No bias-resistant blinded, randomised, trial has yet been performed seeking to measure the benefits of AF ablation.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients who meet the following inclusion criteria will be eligible for the study;

• Ability to give informed consent
• Age 18-80 years
• Persistent AF (atrial fibrillation lasting > 7days) of total continuous duration <2 years as documented in medical notes.
• Patients being considered for cardioversion.

Exclusion Criteria: Patients who meet the following exclusion criteria will be ineligible for study participation;

• Creatinine clearance (eGFR) < 30mls/min
• Contraindication or unable to take anticoagulation
• Known contraindication to or unable to tolerate amiodarone
• Uncontrolled hypertension
• Contraindication to catheter ablation
• BMI > 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

DCCV + PVI

Experimental group

Description:

DC cardioversion (DCCV) plus Pulmonary Vein Isolation (Cryoablation) At end of pulmonary vein isolation, DCCV performed (if patient still in AF). An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.

Treatment:

Procedure: DC Cardioversion

Device: Implantable loop recorder

Procedure: Pulmonary vein isolation

DC cardioversion (DCCV)

Active Comparator group

Description:

Acute treatment of heart rhythm by cardioversion. An implantable loop recorder will be inserted in the prepectoral area with local anaesthetic at the end of the procedure.

Treatment:

Procedure: DC Cardioversion

Device: Implantable loop recorder