NCT03394404: PHENOTYPE-AF

ECG-I Phenotyping of Persistent AF Based on Driver Distribution to Predict Response to Pulmonary Vein Isolation

Completed NA Last updated 22 October 2024

What this trial tests

NA trial testing ECG-I mapping and PVI in Atrial Fibrillation in 140 participants. Completed in 31 March 2021.

Timeline

8 January 2018

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	140
Start date	8 January 2018
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• ECG-I mapping and PVI

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Barts & The London NHS Trust — full company profile →

Who can join

Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation (AF) is an irregular heart rhythm associated with significant morbidity and mortality. The pulmonary veins (the blood vessels carrying blood from the lungs into the left atrium) have been shown to send electrical signals into the heart that can cause and maintain AF. Pulmonary vein Isolation (PVI) is an established treatment where catheters are passed into the atria of the heart to deliver lines of scar to electrically isolate the pulmonary veins preventing them from transmitting these electrical signals into the left atrium.

The ECG-I is a system which involves wearing a jacket with many ECG electrodes to record electrical activity from the surface of the body. A CT scan then shows where these electrodes are relative to the atria, and computer modelling is used to reconstruct the movements of electricity on the surface of the heart and therefore identifying where the drivers (tissue causing and maintaining AF) are located.

Unfortunately, not all patients respond to PVI due to the drivers of AF being located in areas other than within the Pulmonary Veins. Identifying the drivers of AF is very difficult and the role they play has yet to be proved scientifically.

The investigators intend to enroll 100 patients with persistent AF and perform atrial mapping using the ECG-I system. Solely pulmonary vein isolation will be performed. Patients will be followed up to see if the distribution of drivers as predicted by the ECG-I predicts outcomes. This may improve patient selection for this procedure.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. ECGI targeted ablation for persistent AF not responding to pulmonary vein isolation: Results of a two-staged strategy (TARGET AF2).
   Dhillon G, Honarbakhsh S, Abbas H, Waddingham P, et al · · 2023 · cited 4× · PMID 37936670 · DOI 10.1016/j.hroo.2023.08.004
2. ECG-I phenotyping of persistent AF based on driver burden and distribution to predict response to pulmonary vein isolation (PHENOTYPE-AF).
   Dhillon GS, Honarbakhsh S, Graham A, Abbass H, et al · · 2022 · cited 4× · PMID 35924481 · DOI 10.1111/jce.15644
3. Driver characteristics associated with structurally and electrically remodeled atria in persistent atrial fibrillation.
   Dhillon GS, Honarbakhsh S, Graham A, Ahluwalia N, et al · · 2022 · cited 3× · PMID 36589910 · DOI 10.1016/j.hroo.2022.09.016
4. Impact of adenosine on mechanisms sustaining persistent atrial fibrillation: Analysis of contact electrograms and non-invasive ECGI mapping data.
   Dhillon GS, Ahluwalia N, Honarbakhsh S, Graham A, et al · · 2021 · cited 3× · PMID 33765054 · DOI 10.1371/journal.pone.0248951
5. The interconnected atrium: Acute impact of pulmonary vein isolation on remote atrial tissue.
   Rogers AJ, Baykaner T, Narayan SM. · · 2020 · PMID 32090385 · DOI 10.1111/jce.14389