Individualised Mapping in Persistent AF Ablation (IMAGE AF)

Royal Brompton & Harefield NHS Foundation Trust

Status: Not yet enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Pulmonary veins isolation + Cartofinder-guided ablation; Procedure: Pulmonary veins isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT05065112

297733

Details and patient eligibility

About

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.)

Enrollment: 212 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

PVI only

Active Comparator group

Description:

Patients in this arm will undergo only standard pulmonary veins isolation with radiofrequency (RF) energy to treat their AF.

Treatment:

Procedure: Pulmonary veins isolation

PVI + IM

Experimental group

Description:

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.

Treatment:

Procedure: Pulmonary veins isolation + Cartofinder-guided ablation