Individualised Mapping in Persistent AF Ablation

NCT ID: NCT05065112

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-05-31

Brief Summary

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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

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Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PVI only

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

Group Type ACTIVE_COMPARATOR

Pulmonary veins isolation

Intervention Type PROCEDURE

Wide area circumferential pulmonary veins isolation

PVI + IM

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.

Group Type EXPERIMENTAL

Pulmonary veins isolation + Cartofinder-guided ablation

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Pulmonary veins isolation

Wide area circumferential pulmonary veins isolation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vias Markides, MD, FESC

Role: STUDY_DIRECTOR

Royal Brompton Hospital, London, UK

Central Contacts

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Vias Markides, MD, FESC

Role: CONTACT

020 7352 8121

Other Identifiers

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297733

Identifier Type: -

Identifier Source: org_study_id

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