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

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ClinicalTrials.gov Identifier: NCT05195268
Recruitment Status : Not yet recruiting
First Posted : January 18, 2022
Last Update Posted : April 1, 2022
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

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.

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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


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.




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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:
  1. 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

  2. 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



Information from the National Library of Medicine

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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

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
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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
Liverpool Heart and Chest Hospital NHS Foundation Trust
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
Investigators
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Principal Investigator: Dhiraj Gupta, MD Liverpool Heart & Chest Hospital
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Responsible Party: Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05195268    
Other Study ID Numbers: 1349
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
Atrial Fibrillation
Posterior wall isolation
Ablation
Persistent Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes