Individualised Mapping in Persistent AF Ablation

NCT05065112 | Unknown

• 1 other identifier: 297733
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

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.)

Conditions

Persistent Atrial Fibrillation

Keywords

persistent atrial fibrillation; catheter ablation; individualized mapping; focal activity; rotational activity

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmia

  Freedom from any atrial arrhythmia without the use of antiarrhythmic drugs

  12 monts

Secondary Outcomes (3)

• Freedom from atrial fibrillation

  12 months

• Atrial fibrillation burden reduction

  12 months

• Absolute atrial fibrillation burden

  12 months

Study Arms (2)

PVI only

ACTIVE COMPARATOR

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

Procedure: Pulmonary veins isolation

PVI + IM

EXPERIMENTAL

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.

Procedure: Pulmonary veins isolation + Cartofinder-guided ablation

Interventions

Pulmonary veins isolation + Cartofinder-guided ablation PROCEDURE

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.

PVI + IM

Pulmonary veins isolation PROCEDURE

Wide area circumferential pulmonary veins isolation

PVI only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Signed informed consent.
• Scheduled to undergo a clinically indicated, first-time catheter ablation procedure for the treatment of persistent atrial fibrillation.
• In atrial fibrillation at the time of the index procedure.

You may not qualify if:

• Paroxysmal atrial fibrillation.
• Previous ablation procedure for atrial fibrillation.
• Left ventricular ejection fraction \< 45%
• Obesity with BMI \> 35 kg/m2
• Congenital heart disease.
• Previous cardiac surgery with atriotomy.
• Previous left atrial appendage closure/ligation.
• Contraindications to systemic anticoagulation, catheter ablation, and/or general anaesthesia.
• Pregnancy
• Current enrolment in a study evaluating another device or drug.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vias Markides, MD, FESC

  Royal Brompton Hospital, London, UK

  STUDY DIRECTOR

Central Study Contacts

Vias Markides, MD, FESC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share