MedTrace Logo

Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)

NCT06096246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Persistent Atrial Fibrillation
  • Cardiac Arrhythmia
  • Catheter Ablation

Interventions

PROCEDURE

Pulmonary 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.

PROCEDURE

DC 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.

DEVICE

Implantable 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 .

PROCEDURE

Femoral sheath insertion

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

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Richard Schilling, FRCP MD · Barts & The London NHS Trust

  • Malcolm Finlay · Barts & The London NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2027-07-26
Completion
2027-12-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096246 on ClinicalTrials.gov