MedTrace Logo

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

NCT03394404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-10-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

ECG-I mapping and PVI

ECG-I mapping and PVI

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Ross Hunter · Barts Heart Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394404 on ClinicalTrials.gov