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

NCT02950844 | Completed

• 2 other identifiers: 011040PG/16/10/32016
• Study Type: interventional
• Target: 60
• 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 ageing 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 contributed to our limited ability to find the areas that drive the 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 that have already been demonstrated. Data from this study will be used to refine the identification of drivers in the fibrillation left atrium with enormous potential to simplify ablation and improve success rates and thereby reducing the need for further procedures. To better validate this mapping system the investigators also aim to use it in participants 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. The investigators will demonstrate that the STAR mapping algorithm can effectively map AT. To gain further understanding of the changes that occur in the left upper chamber of the heart in the context of AF half of the participants with AF will undergo cardiac magnetic resonance imaging to assess for the presence of scar. This will enhance our understanding of how atrial remodelling promotes AF, which may point to ways of modifying this process and preventing AF.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Electrogram; Ablation; Drivers

Outcome Measures

Primary Outcomes (3)

• Number of participants with AT that have STAR maps that are consistent with conventional maps.

  The number of participants with AT that have STAR maps acquired with multi-polar mapping catheters (basket or other) that yield consistent maps with mechanisms corresponding to those identified by conventional mapping.

  During the catheter ablation

• Number of participants with AF that have STAR maps that suggest a small number of drivers sustain AF.

  The number of participants with consecutive STAR maps acquired with multi-polar mapping catheters (basket or other) that demonstrate a consistent proportion of wave fronts with a given activation pattern suggesting a small number of drivers (whether consistent or intermittent) sustaining AF.

  During the catheter ablation

• Number of participants with AF and AT that have an ablation effect.

  The number of participants that had a response to ablation (slowing or termination of AT/AF) that is consistent with the mechanism of AT/AF identified by the STAR mapping.

  During the catheter ablation

Secondary Outcomes (2)

• The number of driver sites that correlate with sites of scar.

  30 min up to 1 hour (CMR) and during study

• The number of sites in the left atrium with altered conduction that correlate with sites of scar.

  During the catheter ablation

Study Arms (1)

STAR mapping guided ablation

EXPERIMENTAL

Patients will undergo PVI guided ablation in addition to STAR mapping guided ablation. The impact on electrophysiological endpoints including cycle length prolongation and AF termination will be assessed.

Other: Novel mapping algorithm

Interventions

Novel mapping algorithm OTHER

Mapping and ablation of atrial fibrillation drivers identified by the STAR mapping algorithm. In a sub-study a novel mapping system (CARTOFINDER, Biosense Webster, Inc, CA) was used in mapping drivers in AF.

Also known as: STAR MAPPING

STAR mapping guided ablation

Eligibility Criteria

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

You may qualify if:

• Patients able to provide informed consent
• Patients with AT (whether de novo or occuring post AF ablation) undergoing catheter ablation (validation phase)
• Patients with early persistent AF \<24months undergoing their first catheter ablation (mapping phase)

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

Related Publications (2)

• Honarbakhsh S, Schilling RJ, Finlay M, Keating E, Hunter RJ. Prospective STAR-Guided Ablation in Persistent Atrial Fibrillation Using Sequential Mapping With Multipolar Catheters. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008824. doi: 10.1161/CIRCEP.120.008824. Epub 2020 Sep 9.

  PMID: 32903033 DERIVED

• Honarbakhsh S, Hunter RJ, Ullah W, Keating E, Finlay M, Schilling RJ. Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method. JACC Clin Electrophysiol. 2019 Jul;5(7):817-829. doi: 10.1016/j.jacep.2019.04.007. Epub 2019 May 8.

  PMID: 31320010 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 14, 2022

Record last verified: 2019-07

Locations

GB (1)