Individualised Mapping in Persistent AF Ablation

Not Applicable

Not yet recruiting

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary veins isolation; Procedure: Pulmonary veins isolation + Cartofinder-guided ablation

• Registration Number: NCT05065112
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

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.)

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01
• Study Start: 2021-11
• Primary Completion: 2024-11
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI only	Pulmonary veins isolation	Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.
PVI + IM	Pulmonary veins isolation + Cartofinder-guided ablation	Patients in this arm will undergo standard wide area circumferential pulmonary veins isolation along with radiofrequency energy and additional RF ablation guided by individualised mapping with Cartofinder to treat their AF.

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmia	12 monts	Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs

Secondary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation	12 months	Freedom from atrial fibrillation without the use of antiarrhythmic drugs
Atrial fibrillation burden reduction	12 months	Reduction of the atrial fibrillation burden by 75% compared to baseline
Absolute atrial fibrillation burden	12 months	Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach.