Individualised Mapping in Persistent AF Ablation

Royal Brompton & Harefield NHS Foundation Trust212 enrolled

Overview

A clinical randomised trial to compare strategies for ablation in persistent and long-standing persistent atrial fibrillation comprising of two arms: pulmonary veins isolation (PVI) only and PVI + individualised mapping-guided ablation (Cartofinder, Biosense Webster Inc.)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

Persistent Atrial Fibrillation

Interventions

Pulmonary veins isolation + Cartofinder-guided ablationPROCEDURE

The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.

Pulmonary veins isolationPROCEDURE

Wide area circumferential pulmonary veins isolation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 18 years old 2. Signed informed consent. 3. Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation. 4. In atrial fibrillation at the time of the index procedure. Exclusion Criteria: 1. Paroxysmal atrial fibrillation. 2. Previous ablation procedure for atrial fibrillation. 3. Left ventricular ejection fraction \< 45% 4. Obesity with BMI \> 35 kg/m2 5. Congenital heart disease. 6. Previous cardiac surgery with atriotomy. 7. Previous left atrial appendage closure/ligation. 8. Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia. 9. Pregnancy 10. Current enrolment in a study evaluating another device or drug.

Outcomes

Primary Outcomes

Freedom from atrial arrhythmia

Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs

Time frame: 12 monts

Secondary Outcomes

Freedom from atrial fibrillation

Freedom from atrial fibrillation without the use of antiarrhythmic drugs

Time frame: 12 months

Atrial fibrillation burden reduction

Reduction of the atrial fibrillation burden by 75% compared to baseline

Time frame: 12 months

Absolute atrial fibrillation burden

Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.

Time frame: 12 months

Central Contacts

Vias Markides, MD, FESC

CONTACT

020 7352 8121 v.markides@imperial.ac.uk

Data from ClinicalTrials.gov

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