Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF (RABLAP-AF)

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

Study Overview

Status

Withdrawn

Conditions

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart & Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 - PVI + PWI
These patients will receive pulmonary vein isolation and posterior wall isolation.
Both arms will receive intracardiac catheter ablation procedures as described.
Other: Group 2 - PVI only
These patients will receive pulmonary vein isolation only.
Both arms will receive intracardiac catheter ablation procedures as described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first day with ATA burden of 12 hours or greater
Time Frame: 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
From 3 months post ablation to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first day with ATA burden of 24 hours
Time Frame: 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
From 3 months post ablation to 12 months
Time to first day with ATA burden of 60 minutes or greater
Time Frame: 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
From 3 months post ablation to 12 months
Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12
Time Frame: 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.
12 months
Reduction in burden of AF between pre-ablation and months 3-12
Time Frame: 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.
12 months
Difference in AFEQT questionnaire between baseline and month 12
Time Frame: 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
12 months
Difference in EQ5D questionnaire between baseline and month 12
Time Frame: 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
12 months
Difference in VAS between baseline and month 12
Time Frame: 12 months
Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up
12 months
Use of antiarrhythmic drugs from month 3 onwards
Time Frame: From 3 months post ablation to 12 months
Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.
From 3 months post ablation to 12 months
Use of direct current cardioversion or repeat ablation
Time Frame: From 3 months post ablation to 12 months
Number of patients requiring cardioversion or repeat ablation
From 3 months post ablation to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcome: Number of patients with procedural complications (<2 months post procedure)
Time Frame: Within 2 months of protocol-required invasive procedures
Number of patients suffering a procedure-related complication within 2 months of an invasive procedure as defined in the study protocol
Within 2 months of protocol-required invasive procedures
Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations
Time Frame: 12 months
Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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