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The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

ConditionsCardiac ArrhythmiaAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorImperial College London

About this trial

Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes.

The best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people.

The study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs).

The study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females from 18 to 85yrs old

Symptomatic paroxysmal atrial fibrillation

Suitable candidate for catheter ablation

Signed informed consent

Disqualifiers

Contraindication to catheter ablation

Contraindication for general anaesthetic

Presence of a left ventricular thrombus

Valvular disease that is grade moderate or greater

Trial design

Design model

Parallel

Treatments tested in this trial

  • Right Atrial ganglionated plexus ablation

    Procedure/Surgery

    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.

  • Holter Monitor

    Diagnostic test

    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

  • Pulmonary vein isolation

    Procedure/Surgery

    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.

  • Right cavo-tricuspid and left roof linear ablation

    Procedure/Surgery

    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.

  • Personal ECG recordings

    Diagnostic test

    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.

  • Quality of life questionnaire

    Other intervention

    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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 5 interventions
Group B: ControlActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

atrial arrhythmia lasting >30secs

Any recorded atrial arrhythmia lasting \>30seconds will meet the primary endpoint for the trial.

Time frame
1 year

Secondary outcomes

1

Complications

Number of patients experiencing a procedural complication.

Time frame
1 year
2

Usage of antiarrhythmic drugs

number of patients using antiarrhythmic drugs to control symptoms and pathology of AF

Time frame
1 year
3

Quality of life questionnaire

Quality of life will be assess pre and post procedure to assess if any improvement has been seen post procedure. An increase in the AFEQT questionnaire score will reflect a decrease in quality of life

Time frame
1 year
4

Re-do procedures

number of repeat procedures will be assessed and compared between the to arms

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov
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