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

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Intracardiac Catheter Ablation

• Registration Number: NCT05195268
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Study Start: 2022-07-01
• Status Verified: 2022-09
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - PVI only	Intracardiac Catheter Ablation	These patients will receive pulmonary vein isolation only.
Group 1 - PVI + PWI	Intracardiac Catheter Ablation	These patients will receive pulmonary vein isolation and posterior wall isolation.

Primary Outcome Measures

Name	Time	Method
Time to first day with ATA burden of 12 hours or greater	From 3 months post ablation to 12 months	Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation

Secondary Outcome Measures

Name	Time	Method
Reduction in burden of AF between pre-ablation and months 3-12	12 months	AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods.
Time to first day with ATA burden of 24 hours	From 3 months post ablation to 12 months	Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation
Difference in AFEQT questionnaire between baseline and month 12	12 months	Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up
Use of direct current cardioversion or repeat ablation	From 3 months post ablation to 12 months	Number of patients requiring cardioversion or repeat ablation
Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12	12 months	AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction.
Use of antiarrhythmic drugs from month 3 onwards	From 3 months post ablation to 12 months	Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.
Time to first day with ATA burden of 60 minutes or greater	From 3 months post ablation to 12 months	Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation
Difference in EQ5D questionnaire between baseline and month 12	12 months	Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up
Difference in VAS between baseline and month 12	12 months	Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up

Trial Locations

Locations (1)

Liverpool Heart & Chest Hospital; 🇬🇧 Liverpool, United Kingdom