Clinical trial NCT05195268: Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
Official title: Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Posterior wall isolation
Ablation
Persistent Atrial Fibrillation
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
name: Royal Brompton & Harefield NHS Foundation Trust
name: St George's University Hospitals NHS Foundation Trust
name: University Hospital Plymouth NHS Trust
name: South Tees Hospitals NHS Foundation Trust
name: Manchester University NHS Foundation Trust
name: Guy's and St Thomas' NHS Foundation Trust
name: Papworth Hospital NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
name: University Hospitals Dorset NHS Foundation Trust
name: University Hospital Birmingham NHS Foundation Trust
name: Onze Lieve Vrouw Hospital
name: AZ Sint-Jan AV
name: University of Liverpool
First posted: 2022-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first day with ATA burden of 12 hours or greater
timeFrame: From 3 months post ablation to 12 months
Secondary outcomes:
measure: Time to first day with ATA burden of 24 hours
timeFrame: From 3 months post ablation to 12 months
measure: Time to first day with ATA burden of 60 minutes or greater
timeFrame: From 3 months post ablation to 12 months
measure: Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12
timeFrame: 12 months
measure: Reduction in burden of AF between pre-ablation and months 3-12
timeFrame: 12 months
measure: Difference in AFEQT questionnaire between baseline and month 12
timeFrame: 12 months
measure: Difference in EQ5D questionnaire between baseline and month 12
timeFrame: 12 months
measure: Difference in VAS between baseline and month 12
timeFrame: 12 months
measure: Use of antiarrhythmic drugs from month 3 onwards
timeFrame: From 3 months post ablation to 12 months
measure: Use of direct current cardioversion or repeat ablation
timeFrame: From 3 months post ablation to 12 months
Other outcomes:
measure: Safety Outcome: Number of patients with procedural complications (<2 months post procedure)
timeFrame: Within 2 months of protocol-required invasive procedures
measure: Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations
timeFrame: 12 months
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
Study officials:
affiliation: Liverpool Heart & Chest Hospital
name: Dhiraj Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: