Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Atrial Fibrillation Clinical Trial

— RABLAP-AF  

Official title:

Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05195268
• Other study ID #: 1349
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 12, 2022

Study information

• Verified date: September 2022
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Intracardiac Catheter Ablation
Both arms will receive intracardiac catheter ablation procedures as described.

Locations

Country	Name	City	State
United Kingdom	Liverpool Heart & Chest Hospital	Liverpool

Sponsors (15)

Lead Sponsor

Collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

AZ Sint-Jan AV, Biosense Webster, Inc., Guy's and St Thomas' NHS Foundation Trust, Manchester University NHS Foundation Trust, Onze Lieve Vrouw Hospital, Papworth Hospital NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, South Tees Hospitals NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, University Hospital Plymouth NHS Trust, University Hospitals Dorset NHS Foundation Trust, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome: Number of patients with procedural complications (<2 months post procedure)	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
Other	Safety Outcome: Number of patients undergoing planned and unplanned cardiovascular-related hospitalisations	Number of patients who are hospitalised (planned or unplanned) for cardiovascular reasons	12 months
Primary	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	From 3 months post ablation to 12 months
Secondary	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	From 3 months post ablation to 12 months
Secondary	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	From 3 months post ablation to 12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Use of antiarrhythmic drugs from month 3 onwards	Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.	From 3 months post ablation to 12 months
Secondary	Use of direct current cardioversion or repeat ablation	Number of patients requiring cardioversion or repeat ablation	From 3 months post ablation to 12 months