The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

NARecruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

February 21, 2023

Primary Completion Date

February 21, 2026

Study Completion Date

December 2, 2027

Conditions
Cardiac ArrhythmiaAtrial Fibrillation
Interventions
PROCEDURE

Right Atrial ganglionated plexus ablation

"A 3D electroanatomic map of the right atrium will be made. During sinus rhythm, the ablation catheter will be positioned at a spot to test with HFS. The right atrium will be paced at a fixed rate, for up to four beats to ensure that there is no ventricular capture then a short burst of HFS will be synchronized to each paced stimulus for up to 15 trains. This will be performed using a custom-built GP stimulator that has been validated for reproducibility against Grass Stimulator (AstroMed).~All Sites will be marked on the 3D map and the positive sites will be ablated at the end of the mapping. If the patient converts to AF, then DC cardioversion will be performed. If mapping in sinus rhythm is not feasible, HFS will be performed continuously for several seconds to identify atrioventricular dissociating GPs (AVD-GPs).~Every ablated GP site will be re-tested with HFS at the end of the procedure until they are all rendered non-functional."

DIAGNOSTIC_TEST

Holter Monitor

"48 hour Holter monitors will be performed post procedure to monitor for recurrence of AF.~These will be performed at 3, 6, 9, 12 months"

PROCEDURE

Pulmonary vein isolation

"Transseptal puncture for access into the left atrium will be guided by TOE and fluoroscopy.~ACT will be maintained at 300s with heparin. A 3D electroanatomic map of the left atrium will be created and all PVs will be identified. Touch-up radiofrequency ablation will be performed at electrical gaps around the reconnected PVs until complete PVI is achieved."

PROCEDURE

Right cavo-tricuspid and left roof linear ablation

CONTROL ARM (Redo-PVI) only: If all Pulmonary veins are isolated at the start of the procedure, the operator will be allowed to perform a right cavo-tricuspid and left roof linear ablation.

DIAGNOSTIC_TEST

Personal ECG recordings

All patients will be provided with an AliveCor KardiaMobile-6L ECG recorder. The device will continue to be used within its CE-marked and NICE-approved purpose. Patients will be asked to take a daily recording from this, once the blanking period is over, in addition to taking a recording if symptomatic. Patients will submit this to the connected care team at Hammersmith Hospital via a secure NHS.net email address, who will assess the recordings both for the study and clinical purposes.

OTHER

Quality of life questionnaire

A Quality of life questionnaire will be performed at baseline, 6 and 12 months to assess the effect of the procedures on patients quality of life.

Trial Locations (1)

W12 0HS

RECRUITING

Hammersmith Hospital, London

All Listed Sponsors
lead

Imperial College London

OTHER