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

NCT06335446 | Completed

• 2 other identifiers: 011040- AT validation phasePG/16/10/32016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Tachycardia

Keywords

Atrial tachycardia, Electrogram, Ablation, Drivers

Outcome Measures

Primary Outcomes (1)

• STAR maps compared to conventional maps

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

  At procedure

Study Arms (1)

Atrial tachycardia- validation phase

The group will consist of patients with AT (whether de novo or occurring post AF ablation) that are undergoing catheter ablation.

Other: Novel mapping algorithm

Interventions

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.

Also known as: STAR MAPPING

Atrial tachycardia- validation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AT (whether de novo or occurring post AF ablation) undergoing catheter ablation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: March 28, 2024
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

GB (1)