ClinicalTrialsFinder
RecruitingNot ApplicableNCT06096246

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)

Sponsor

Barts & The London NHS Trust

Enrollment

208 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Catheter AblationPersistent Atrial FibrillationCardiac Arrhythmia

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

The ORBICA-AF study is comparing two strategies for managing persistent atrial fibrillation (AF) — an irregular heartbeat lasting more than 7 days — in patients being considered for treatment: electrical cardioversion (a shock to reset the heart rhythm) versus catheter ablation (a procedure that destroys the abnormal tissue causing the irregular rhythm). **You may be eligible if...** - You are between 18 and 85 years old - You have persistent atrial fibrillation lasting more than 7 days but less than 2 years total - You are being evaluated for cardioversion to restore normal heart rhythm - You are able to give informed consent **You may NOT be eligible if...** - Your kidney function is severely reduced (eGFR below 30) - You cannot take blood thinners or have a contraindication to them - You have uncontrolled high blood pressure - Your BMI is above 40 - You have already had more than one cardioversion for this episode of AF - You have hypertrophic cardiomyopathy (a specific thickening of the heart muscle) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREPulmonary vein isolation

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.

PROCEDUREDC Cardioversion

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.

DEVICEImplantable loop recorder

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 .

PROCEDUREFemoral sheath insertion

Two femoral sheaths (7Fr) will be inserted using ultrasound guidance under local anaesthetic.

Locations(1)

Barts Heart Centre

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06096246

Related Trials

PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

NCT071069701 location

Feasibility Study of the FARAFLEX Mapping and PFA System

NCT065105564 locations

Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation

NCT048232992 locations

REPRESENT-PF Registry

NCT075352682 locations

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)

NCT0729847330 locations