The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

NCT05539040 | Recruiting

• 2 other identifiers: PA2481314366
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Arrhythmia; Atrial Fibrillation

Keywords

Atrial Fibrillation; Ganglionated plexus; Arrhythmia; Cardiology; Right atrium; Ectopy; Electrophysiology; GP; AF

Outcome Measures

Primary Outcomes (1)

• atrial arrhythmia lasting >30secs

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

  1 year

Secondary Outcomes (5)

• Complications

  1 year

• Usage of antiarrhythmic drugs

  1 year

• Quality of life questionnaire

  1 year

• Re-do procedures

  1 year

• Radiofrequency time

  day of the procedure.

Study Arms (2)

Intervention

EXPERIMENTAL

Right atrial GP ablation in addition to pulmonary vein isolation

Procedure: Right Atrial ganglionated plexus ablation; Diagnostic Test: Holter Monitor; Procedure: Pulmonary vein isolation; Diagnostic Test: Personal ECG recordings; Other: Quality of life questionnaire

Control

ACTIVE COMPARATOR

PVI alone with no GP mapping or ablation

Diagnostic Test: Holter Monitor; Procedure: Pulmonary vein isolation; Procedure: Right cavo-tricuspid and left roof linear ablation; Diagnostic Test: Personal ECG recordings; Other: Quality of life questionnaire

Interventions

Right Atrial ganglionated plexus ablation PROCEDURE

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.

Intervention

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

Control; Intervention

Pulmonary vein isolation PROCEDURE

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.

Control; Intervention

Right cavo-tricuspid and left roof linear ablation PROCEDURE

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.

Control

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.

Control; Intervention

Quality of life questionnaire OTHER

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females from 18 to 85yrs old
• Symptomatic paroxysmal atrial fibrillation
• Suitable candidate for catheter ablation
• Signed informed consent

You may not qualify if:

• Contraindication to catheter ablation
• Contraindication for general anaesthetic
• Presence of a left ventricular thrombus
• Valvular disease that is grade moderate or greater
• Any form of cardiomyopathy
• Severe cerebrovascular disease
• Active gastrointestinal bleeding
• Serum Creatinine \>200umol/L/ on dialysis/ at risk of dialysis
• Active infection or fever
• Life expectancy shorter than the duration of the trial
• Allergy to contrast
• Moderate to severe heart failure and/or NYHA Class III-IV
• Bleeding or clotting disorders or inability to receive heparin
• Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
• Malignancy needing therapy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Prapa Kanagaratnam, MBBChir, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Kay, MBBS BMedSci

CONTACT

02033131000; jamie.kay@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single centre pilot study with a control arm and outcomes will be measured prospectively on both an intention-to-treat and per-protocol basis.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: February 21, 2023
• Primary Completion: February 21, 2026
• Study Completion (Estimated): December 2, 2027
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)