Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation

NACompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 3, 2020

Primary Completion Date

March 11, 2024

Study Completion Date

March 11, 2024

Conditions
Atrial FibrillationPersistent Atrial Fibrillation
Interventions
PROCEDURE

Cryoballoon pulmonary vein isolation

Catheter ablation using cryoballoon pulmonary vein isolation. Utilisation of a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 pulmonary veins to achieve electrical isolation.

PROCEDURE

Radiofrequency pulmonary vein isolation

Catheter ablation using radiofrequency energy to achieve pulmonary vein isolation. Radiofrequency energy is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 pulmonary veins at their bases

PROCEDURE

Repeat electrophysiological study

All participants will receive a repeat electrophysiological study 2 months after the index procedure during which radiofrequency catheter ablation guided by ultra-high density mapping will be used to identify regions of reconnection that need re-isolation; other tests will be carried out including testing for arrhythmia inducibility

PROCEDURE

Left atrial posterior wall isolation

The left atrial posterior wall will be isolated in Group 2 participants (those who received radiofrequency ablation at the index procedure) during the repeat electrophysiological study in 2 months

Trial Locations (3)

L14 3PE

Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool

M13 9WL

Manchester University NHS Foundation Trust, Manchester

NE7 7DN

The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

NCT04111731 - Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation | Biotech Hunter | Biotech Hunter