- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05195268
Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF (RABLAP-AF)
Study Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Liverpool, United Kingdom, L14 3PE
- Liverpool Heart & Chest Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Both arms will receive intracardiac catheter ablation procedures as described.
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Other: Group 2 - PVI only
These patients will receive pulmonary vein isolation only.
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Both arms will receive intracardiac catheter ablation procedures as described.
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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
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Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation
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From 3 months post ablation to 12 months
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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
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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
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Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation
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From 3 months post ablation to 12 months
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Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12
Time Frame: 12 months
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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.
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12 months
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Reduction in burden of AF between pre-ablation and months 3-12
Time Frame: 12 months
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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
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Difference in AFEQT questionnaire between baseline and month 12
Time Frame: 12 months
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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
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12 months
|
Difference in EQ5D questionnaire between baseline and month 12
Time Frame: 12 months
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Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up
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12 months
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Difference in VAS between baseline and month 12
Time Frame: 12 months
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Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up
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12 months
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Use of antiarrhythmic drugs from month 3 onwards
Time Frame: From 3 months post ablation to 12 months
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Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.
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From 3 months post ablation to 12 months
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Use of direct current cardioversion or repeat ablation
Time Frame: From 3 months post ablation to 12 months
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Number of patients requiring cardioversion or repeat ablation
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From 3 months post ablation to 12 months
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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
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Number of patients suffering a procedure-related complication within 2 months of an invasive procedure as defined in the study protocol
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Within 2 months of protocol-required invasive procedures
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Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations
Time Frame: 12 months
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Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dhiraj Gupta, MD, Liverpool Heart & Chest Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1349
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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