Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained heart rhythm abnormality. Its incidence is increasing partly due to the aging population and it has been referred to as a growing epidemic. AF results in irregular contractions of the heart causing unpleasant symptoms of palpitations and increasing the risk of stroke, heart failure and death. Percutaneous catheter ablation is a safe treatment option in symptomatic patients with AF. The success rate of these procedures have improved with time due to our better understanding of AF, development of new techniques and technology, and greater physician experience. However, the success rate of these procedures still only remains around 70%. This is secondary to our limited ability to find the areas that drive AF.

STAR mapping is a novel mapping system that has been developed with a view of better identifying the sites that drive AF through taking into account the mechanisms of AF we have so far demonstrated. To validate this mapping system we aim to use it in patients with atrial tachycardia (AT), which is a heart rhythm abnormality of which the mechanism can be readily identified with the existing mapping systems used in clinical practice. We will demonstrate that the STAR mapping algorithm can effectively map AT.

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Key information

Conditions

Atrial Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barts Heart Centre

London, EC1A 7BE, United Kingdom

About this study

AT is a heart rhythm that currently can be effectively mapped and ablated using existing mapping systems. The mechanism of this heart rhythm is well understood.

Patients that are scheduled for a catheter ablation for AT by their Electrophysiologist will be enrolled into the study. The patient will have the procedure under local anaesthetics/sedation or general anaesthetic depending on their clinical need.

During the procedure tubes will be passed into the left upper chamber of the heart through the groin. Through these tubes catheters will be used to create a geometry of the heart chamber. Following this, in half of the patients a basket catheter with 64 electrodes will be positioned in the upper chamber whilst conventional catheters will be used in the other half of the patients. The aim of this is to demonstrate that the STAR mapping can be used with multiple mapping catheters. Signals i.e. electrograms will then be collected and used with the STAR mapping algorithm. The AT will then be effectively mapped and ablated with a conventional mapping system. The STAR mapping will then be used for post processing after the case to map the AT and will be compared to the maps generated by the conventional system. This will enable validation of the STAR mapping system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients able to provide informed consent
Patients with AT (whether de novo or occurring post AF ablation)

Exclusion criteria

Unwillingness to sign consent
Age <18 years old
Contraindications for catheter ablation procedure

Treatment and study plan

Novel mapping algorithm

Other

Signals will be collected during the catheter ablation. These signals STAR maps will be created post procedure and these will be compared to the conventional maps used during the atrial tachycardia ablation. This will be used to validate the STAR maps created.

Other names: STAR MAPPING

Primary outcomes

STAR maps compared to conventional maps

Time frame: At procedure

The STAR maps demonstrating the source of the AT correlate with the maps created by the conventional mapping system.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

Identification, Electro-mechanical Characterisation and Ablation of Driver Regions in Persistent Atrial Fibrillation (STAR Mapping)

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 28, 2024
Registry last updated: Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed