Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Barts Heart Centre
RECRUITING
London
Contact Information
Primary
Malcolm Finlay, FRCP PhD
malcolm.finlay1@nhs.net
02037658635
Backup
Vijayabharathy Kanthasamy, MRCP
vijayabharathy.kanthasamy@nhs.net
02037658635
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2027-12-05
Participants
Target number of participants: 208
Treatments
Active_comparator: Experimental: DCCV + PVI
An implantable loop recorder will be inserted in the pre pectoral area with local anaesthetic at least one week before the randomisation.~Two femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for ablation and for phrenic nerve pacing during the procedure.~DC cardioversion (DCCV) plus Pulmonary Vein Isolation - At the end of pulmonary vein isolation, DCCV is performed (if the patient is still in AF).
Sham_comparator: DC cardioversion (DCCV) + Sham procedure
An implantable loop recorder will be inserted in the pre-pectoral area with local anaesthetic at least one week before the randomisation.~Two femoral sheaths will be inserted at the groin area in all patients on the day of the procedure prior randomisation. This will be utilised as the access route for cardiac catheter insertion for intermittent phrenic nerve pacing during the procedure.~DC Cardioversion and Sham procedure will be performed after randomisation. Intermittent phrenic nerve pacing will be employed for the sham group through the femoral venous sheath using a quadripolar catheter.
Related Therapeutic Areas
Sponsors
Leads: Barts & The London NHS Trust

This content was sourced from clinicaltrials.gov