Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-09-12

Brief Summary

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RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).

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Detailed Description

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Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF.

A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF.

The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.

Study Groups

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Group 1 - PVI + PWI

These patients will receive pulmonary vein isolation and posterior wall isolation.

Group Type ACTIVE_COMPARATOR

Intracardiac Catheter Ablation

Intervention Type PROCEDURE

Both arms will receive intracardiac catheter ablation procedures as described.

Group 2 - PVI only

These patients will receive pulmonary vein isolation only.

Group Type OTHER

Intracardiac Catheter Ablation

Intervention Type PROCEDURE

Both arms will receive intracardiac catheter ablation procedures as described.

Interventions

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Intracardiac Catheter Ablation

Both arms will receive intracardiac catheter ablation procedures as described.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 80 (inclusive)
* Patients with symptomatic advanced persistent AF, defined as:
* AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND
* Recurs following cardioversion, AND
* Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed.

Exclusion Criteria

* Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable)
* An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium
* Severe left ventricular systolic dysfunction (ejection fraction less than 35%)
* Recent stroke/transient ischaemic attack within 3 months
* Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication
* Severe kidney function impairment (eGFR less than 30ml/min/1.73m2)
* Morbid obesity with a body mass index ≥40
* Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale)
* Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No