Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate (Unmask-AF)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT06657170
- Lead Sponsor
- Centro Medico Teknon
- Brief Summary
Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. However, there is still a notable lack of randomized evidence in this area, which limits guidance and decision-making in clinical practice. Recently, the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms (EGMs) in AF patients, termed as hidden slow conduction (HSC). Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate, offering a potential target for ablation This multi-center, prospective, randomized, controlled trial will include two arms: one investigational (PV reconnection + HSC) and one control (PV reconnection). All the subjects will be followed for 12 months after the ablation procedure.
The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures. The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 212
- Recurrent paroxysmal AF (continuous AF episode lasting longer than 30 s but terminating spontaneously or with intervention within 7 days of onset), recurrent persistent AF (continuous AF episode lasting longer than 7 days but < 1 year) and recurrent long standing persistent AF (continuous AF ≥1 year in duration, in patients where rhythm control management is being pursued)
- Previous PVI procedure
- Age > 40 years
- Willing and capable of providing consent
- Able and willing to comply with all follow-up testing and requirements
- Additional left atrial ablations during the previous procedures (es. posterior wall isolation, anterior line, roof line, CFAE and others)
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Severe mitral regurgitation
- Women who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Atrial arrhythmias recurrence up to 12 moths The primary endpoint of the study aims to establish the impact of targeting HSC sites alongside PV gaps in repeat ablation procedures for patients with recurrent AF. Specifically evaluating the freedom from atrial tachyarrhythmia recurrence (documented AF/AT/AFL lasting at least 30s).
- Secondary Outcome Measures
Name Time Method Burden of atrial arrhythmias up to 12 moths Arrhythmic burden (average percentage of time in AF/AT in 24h Holter)
incidence of periprocedural complications (pericardial effusion) up to 12 months incidence of periprocedural complications such as pericardial effusion
Use of antiarrhythmic drugs up to 12 months Use of antiarrhythmic drugs after the blanking period of 60 days.
incidence of periprocedural complications (peripheral complication) up to 12 moths incidence of periprocedural complications such as peripheral complication
incidence of periprocedural complications (transient ischemic attack or stroke) up to 12 months incidence of periprocedural complications such as transient ischemic attack or stroke