MedTrace Logo

ECG-I Targeted Ablation for Persistent AF

NCT04632680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

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. Catheter ablation is an established treatment where catheters are inserted through a vein in the leg into the left atrium of the heart to deliver lines of scar to disrupt the tissue causing and maintaining AF.

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.

Success rates for persistent atrial fibrillation lie in the region of 30-60% due to the location of drivers (tissue causing and maintaining AF) varying per patient. Locating and treating these drivers is very challenging.

We intend to enrol 40 patients with persistent AF and perform atrial mapping using the ECG-I system. We will perform pulmonary vein isolation and perform atrial mapping to identify the location of these drivers and then to ablate them. We will study the effects of performing ablation upon these drivers using the ECG-I.

Conditions

Interventions

DEVICE

PVI followed by targeting of drivers

Patients will undergo intraprocedural ECG-I mapping. The pulmonary veins will be isolated followed by targeting of drivers aiming to terminate AF.

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
2019-01-10
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 NCT04632680 on ClinicalTrials.gov