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

NCT03394404 | Completed DMC FDA Device

• 1 other identifier: 218367-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

ECG-I Mapping Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Freedom from Atrial Arrhythmia and association with distribution of drivers of AF

  All patients will undergo mapping with ECG-I during their procedure. The number of drivers and their locations will be collected. Patients who remain free from AF at 12 months will be compared to patients who relapsed comparing the number and location of these drivers.

  Performed 12-14 months post procedure

Secondary Outcomes (1)

• Impact of pulmonary vein isolation on drivers of AF

  During AF Catheter Ablation

Study Arms (1)

ECG-I mapping and PVI

EXPERIMENTAL

ECG-I mapping and PVI

Device: ECG-I mapping and PVI

Interventions

ECG-I mapping and PVI DEVICE

ECG-I mapping and PVI

ECG-I mapping and PVI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Persistent AF (i.e. episodes of AF that are continuous for \> 1 week or have required DC cardioversion)
• Willing for ablation.
• Age between 18 to 80.
• left atrial diameter \<5 cm
• left ventricular function \>40%.
• New York Heart Association class \< 3.

You may not qualify if:

• Persistent AF diagnosed \> 2 years ago
• left atrial diameter \> 5 cm
• Severe left ventricular impairment (EF \< 40%)
• New York Heart Association class 3 or 4 heart failure
• Known hypertrophic cardiomyopathy, cardiac sarcoid, or arrythmogenic ventricular cardiomyopathy.
• Known inherited arrhythmia such as Brugada or long QT syndromes
• Valvular disease that is more than moderate
• History of valve replacement (metallic or tissue)
• History of congenital heart disease (other than patent foramen ovale)
• Previous left atrial ablation (percutaneous or surgical)
• Cardiac surgery or percutaneous coronary intervention within the last 3 months.
• Myocardial infarction or unstable angina within the last 3 months.
• Unwillingness for ablation
• Unwillingness to be involved in study
• Suspected reversible cause of AF

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Heart Centre

London, EC1A 7BE, United Kingdom

Location

Related Publications (3)

• Dhillon GS, Honarbakhsh S, Graham A, Abbass H, Welch S, Daw H, Sporton S, Providencia R, Chow A, Earley MJ, Lowe M, Lambiase PD, Schilling RJ, Hunter RJ. ECG-I phenotyping of persistent AF based on driver burden and distribution to predict response to pulmonary vein isolation (PHENOTYPE-AF). J Cardiovasc Electrophysiol. 2022 Nov;33(11):2263-2273. doi: 10.1111/jce.15644. Epub 2022 Aug 16.

  PMID: 35924481 DERIVED

• Dhillon GS, Ahluwalia N, Honarbakhsh S, Graham A, Creta A, Abbass H, Chow A, Earley MJ, Lambiase PD, Schilling RJ, Hunter RJ. Impact of adenosine on mechanisms sustaining persistent atrial fibrillation: Analysis of contact electrograms and non-invasive ECGI mapping data. PLoS One. 2021 Mar 25;16(3):e0248951. doi: 10.1371/journal.pone.0248951. eCollection 2021.

  PMID: 33765054 DERIVED

• Dhillon GS, Schilling RJ, Honarbakhsh S, Graham A, Abbass H, Waddingham P, Sawhney V, Creta A, Sporton S, Finlay M, Providencia R, Chow A, Earley MJ, Lowe M, Lambiase PD, Hunter RJ. Impact of pulmonary vein isolation on mechanisms sustaining persistent atrial fibrillation: Predicting the acute response. J Cardiovasc Electrophysiol. 2020 Apr;31(4):903-912. doi: 10.1111/jce.14392. Epub 2020 Mar 1.

  PMID: 32048786 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ross Hunter

  Barts Heart Centre

  PRINCIPAL INVESTIGATOR

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: December 4, 2017
• First Posted: January 9, 2018
• Study Start: January 8, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

GB (1)