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NCT05065112 Clinical Trial

Individualised Mapping in Persistent AF Ablation

Persistent Atrial Fibrillation Clinical Trial

— IMAGE AF  

Official title:
Individualised MApping-Guided Ablation to Improve Outcomes in pErsistent Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05065112
Other study ID # 297733
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2021
Est. completion date May 2025

Study information
Verified date September 2021
Source Royal Brompton & Harefield NHS Foundation Trust
Contact Vias Markides, MD, FESC
Phone 020 7352 8121
Email v.markides@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 212
Est. completion date May 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulmonary veins isolation + Cartofinder-guided ablation
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 isolation
Wide area circumferential pulmonary veins isolation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom from atrial arrhythmia Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs 12 monts
Secondary Freedom from atrial fibrillation Freedom from atrial fibrillation without the use of antiarrhythmic drugs 12 months
Secondary Atrial fibrillation burden reduction Reduction of the atrial fibrillation burden by 75% compared to baseline 12 months
Secondary Absolute atrial fibrillation burden Absolute atrial fibrillation burden after a single, first-time ablative procedure guided by individualised mapping vs. standard approach. 12 months
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