NCT04657978

Substrate Guided Ablation Therapy for Atrial Fibrillation

High Density Substrate Evaluation and Guided Ablation Therapy for Atrial Fibrillation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF), often referred to as an 'irregular heartbeat', is the most common abnormal heart rhythm worldwide. AF may be intermittent (termed paroxysmal) or sustained (termed persistent).Catheter ablation is increasingly being used to manage individuals with AF, however in a significant proportion of cases AF recurs. Such rhythm control interventions are known to be less effective in individuals with persistent AF compared with those with paroxysmal AF. Analysis of heart tissue of individuals with AF show deposition of scar tissue within the heart muscle and this scar tissue promotes abnormal electrical activity that is involved in causing AF. The aim of the proposed study is to evaluate the feasibility and effectiveness of combining conventional pulmonary vein isolation (PVI) during catheter ablation for AF with adjunctive substrate ablation.

Detailed description

This is a single-centre, non-randomized study investigating the feasibility, safety and efficacy of substrate guided ablation in persistent AF. The study population will be patients between the ages of 18 and 80 with symptomatic, persistent atrial fibrillation (≥1 year) referred for catheter ablation on standard clinical grounds. The catheter ablation procedure will be performed using the Precision Ensite™ three dimensional mapping system and the Advisor High Density Grid™ mapping catheter (Abbott Medical Incorporated). All patients will undergo conventional pulmonary vein isolation (PVI). As an adjunctive strategy to PVI, low voltage areas (used as a surrogate for atrial scar), as derived from the voltage map, will be targeted for ablation in order to isolate or homogenise these areas of the atrium. A pre-procedural cardiac magnetic resonance imaging scan will be performed in all patients. All patients will undergo 12 months follow-up with an ECG and ambulatory holter monitoring at 3, 6 and 12 months.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Substrate guided left atrial ablation	Ablation therapy targeting areas of low voltage, which may include encirclement, homogenization or targeting of abnormal electrograms and anchored to a non-conducting structure if the region is in close proximity or likely to create an isthmus for arrhythmias.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-01
• Completion: 2023-01-01
• First posted: 2020-12-08
• Last updated: 2020-12-08