Atrial FibrillationRABLAP-AFNCT05195268
Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
A study testing Intracardiac Catheter Ablation in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Intracardiac Catheter Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE
About this study
RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Intracardiac Catheter Ablation
- Keywords
- Atrial Fibrillation, Posterior wall isolation, Ablation, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac Catheter AblationProcedure or surgery
Both arms will receive intracardiac catheter ablation procedures as described.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - PVI + PWI | Active comparator | These patients will receive pulmonary vein isolation and posterior wall isolation. Receives: Procedure: Intracardiac Catheter Ablation |
| Group 2 - PVI only | Other | These patients will receive pulmonary vein isolation only. Receives: Procedure: Intracardiac Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first day with ATA burden of 12 hours or greater
Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation
Measured: From 3 months post ablation to 12 months
Secondary outcomes (9)
Time to first day with ATA burden of 24 hours
Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation
Measured: From 3 months post ablation to 12 months
Time to first day with ATA burden of 60 minutes or greater
Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation
Measured: 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
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.
Measured: 12 months
Reduction in burden of AF between pre-ablation and months 3-12
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.
Measured: 12 months
Difference in AFEQT questionnaire between baseline and month 12
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
Measured: 12 months
Difference in EQ5D questionnaire between baseline and month 12
Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up
Measured: 12 months
Difference in VAS between baseline and month 12
Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up
Measured: 12 months
Use of antiarrhythmic drugs from month 3 onwards
Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.
Measured: From 3 months post ablation to 12 months
Use of direct current cardioversion or repeat ablation
Number of patients requiring cardioversion or repeat ablation
Measured: From 3 months post ablation to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jul 2022
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: Decision to discontinue in light of new evidence demonstrating that the intervention in question is not effective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Dhiraj Gupta, MD, Principal investigator, Liverpool Heart & Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195268
- Sponsor's protocol ID
- 1349
- Acronym
- RABLAP-AF
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
- ClinicalTrials.gov ID
- NCT05195268
- Acronym / sponsor ID
- RABLAP-AF / 1349
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Posterior wall isolation, Ablation, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision to discontinue in light of new evidence demonstrating that the intervention in question is not effective.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- 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
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised controlled trial with two arms: 1) Pulmonary vein isolation + posterior wall isolation; 2) Pulmonary vein isolation alone
| Arm | Type | Receives |
|---|---|---|
| Group 1 - PVI + PWI | Active comparator | Procedure: Intracardiac Catheter AblationThese patients will receive pulmonary vein isolation and posterior wall isolation. |
| Group 2 - PVI only | Other | Procedure: Intracardiac Catheter AblationThese patients will receive pulmonary vein isolation only. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracardiac Catheter AblationBoth arms will receive intracardiac catheter ablation procedures as described. | Procedure or surgery | Group 1 - PVI + PWI, Group 2 - PVI only |
Primary outcome
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
9 secondary outcomes
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 ATA burden of 60 minutes or greater
Time frame: 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
Reduction in burden of AF between pre-ablation and months 3-12
Time frame: 12 months
Difference in AFEQT questionnaire between baseline and month 12
Time frame: 12 months
Difference in EQ5D questionnaire between baseline and month 12
Time frame: 12 months
Difference in VAS between baseline and month 12
Time frame: 12 months
Use of antiarrhythmic drugs from month 3 onwards
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhiraj Gupta, MD principal investigator
Liverpool Heart & Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac Catheter Ablation in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first day with ATA burden of 12 hours or greater (time frame: From 3 months post ablation to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.