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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05195268

Recruitment Status : Not yet recruiting

First Posted : January 18, 2022

Last Update Posted : April 1, 2022

See Contacts and Locations

Sponsor:

Collaborators:

Biosense Webster, Inc.

Royal Brompton & Harefield NHS Foundation Trust

St George's University Hospitals NHS Foundation Trust

University Hospital Plymouth NHS Trust

South Tees Hospitals NHS Foundation Trust

Manchester University NHS Foundation Trust

Guy's and St Thomas' NHS Foundation Trust

Papworth Hospital NHS Foundation Trust

Portsmouth Hospitals NHS Trust

University Hospitals Dorset NHS Foundation Trust

University Hospital Birmingham NHS Foundation Trust

Onze Lieve Vrouw Hospital

AZ Sint-Jan AV

University of Liverpool

Information provided by (Responsible Party):

Liverpool Heart and Chest Hospital NHS Foundation Trust

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Procedure: Intracardiac Catheter Ablation	Not Applicable

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	125 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
Masking:	Single (Outcomes Assessor)
Masking Description:	Patients and operators will be aware of the treatment arm. Researchers interpreting and assessing outcome data will be blinded to treatment received.
Primary Purpose:	Treatment
Official Title:	Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
Estimated Study Start Date :	April 1, 2022
Estimated Primary Completion Date :	April 1, 2024
Estimated Study Completion Date :	January 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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
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
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.
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.
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
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
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
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.

Other Outcome Measures:

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
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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Age 18 to 80 (inclusive)
Patients with symptomatic advanced persistent AF as defined based on a combination of temporal behaviour of AF, AND the presence of co-morbid conditions:
1. History of continuous AF of 3 months or greater, with early recurrence (within 1 month) after electrical and/or chemical cardioversion, AND the presence of either:
  1. Chadsvasc score >2 in men and >3 in women, OR
  2. Chadsvasc score >1 in men and >2 in women, AND one or more of the following: age 75 years or greater, severe left atrial enlargement on echocardiography (one or more of the following (indexed to body surface area): anteroposterior diameter >3.0cm/m2, 2D area >40cm2/m2 or volume >40ml/m2), chronic kidney disease with eGFR <45ml/min/1.73m2, tachy-brady syndrome with a pacemaker in situ for documented sinus node disease

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195268

Contacts

Layout table for location contacts

Contact: Peter Calvert, MBChB	0151 600 1616	peter.calvert@lhch.nhs.uk
Contact: Wern Yew Ding, MBChB	0151 600 1616	dwyew@hotmail.com

Sponsors and Collaborators