ECG-I Targeted Ablation for Persistent AF Not Responding to Pulmonary Vein Isolation Results of a Two Staged Strategy.

NCT04633265 | Completed DMC FDA Device

• 1 other identifier: 218367-3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial Fibrillation (AF) is a irregular heart rhythm associated with significant morbidity and mortality. Catheter ablation is a treatment where catheters are passed through the veins in the leg into the left atrium of the heart and lines of scar is delivered to disrupt tissue causing and maintaining atrial fibrillation. Current strategies involve isolating the pulmonary veins which have been shown to trigger and maintain AF. However, success rates for persistent AF lie in the region of 30-60% due to the drivers of AF residing elsewhere to the Pulmonary Veins antra. 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. PHENOTYPE AF is an ongoing clinical trial in which 100 patients with persistent AF are receiving cryoballoon pulmonary vein isolation for persistent AF (NCT03394404). Patients with recurrent AF or atrial tachycardia within 1 year following pulmonary vein isolation for AF within this trial will be recruited into this study. Up to 50 such patients who have failed Pulmonary Vein Isolation will be enrolled. These patients will undergo a second procedure at which time participants will undergo catheter ablation of drivers of AF and will then be followed up for 12 months.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation ECG-I Mapping Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Number of Participants free from Atrial Arrhythmia at 12 months

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

  12 months

Secondary Outcomes (2)

• Rates of termination of AF with ECGI guided ablation

  Intra-procedural (day 1)

• Number of participants free from AF at 12 months

  12 months

Study Arms (1)

ECG-I Mapping and Ablation of drivers

EXPERIMENTAL

ECG-I Mapping will be performed and drivers will be ablated as directed by ECG-I.

Device: ECG-I Mapping of Atrial Fibrillation

Interventions

ECG-I Mapping of Atrial Fibrillation DEVICE

Catheter ablation of Atrial Fibrillation guided by ECG-I

ECG-I Mapping and Ablation 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:

• Continuous persistent AF \> 2 years duration
• 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 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: July 10, 2018
• First Posted: November 18, 2020
• Study Start: January 10, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

GB (1)