ECG-I Targeted Ablation for Persistent AF

NCT04632680 | Completed FDA Device

• 1 other identifier: 218367-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Keywords

Atrial Fibrillation ECG-I Mapping Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months

  Number of participants free from atrial arrhythmia (including AF and atrial tachycardia) at 12 months

  12 months

Secondary Outcomes (3)

• Number of participants free from Atrial Fibrillation at 12 months

  12 months

• Termination of AF with PVI followed by ECGI guided driver ablation

  During Catheter Ablation Procedure

• Composite end point including rates of AF termination and cycle length slowing with PVI followed by ECGI guided driver ablation

  During Catheter Ablation Procedure

Study Arms (1)

PVI followed by targeting of drivers

EXPERIMENTAL

Patients will undergo intra-procedural mapping using the ECG-I. The pulmonary veins will be isolated. Drivers will then be targeted as guided by the ECG-I system aiming for termination of AF.

Device: PVI followed by targeting of drivers

Interventions

PVI followed by targeting of drivers DEVICE

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

PVI followed by targeting of drivers

Eligibility Criteria

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

You may qualify if:

• Persistent AF (i.e. episodes of AF that are continuous for \> 1 week)
• Willing for ablation.
• Age between 18 to 80.

You may not qualify if:

• Duration of continuous persistent AF \> 2 years
• 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 Arrhythmogenic 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

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: November 11, 2020
• First Posted: November 17, 2020
• Study Start: January 10, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

GB (1)