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Personalised Ablation Strategies in AF

ConditionAtrium; Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust

About this trial

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Catheter ablation is a safe treatment option in eliminating AF however, success rates still remains variable. Existing strategies do not take into account the differences in AF perpetuation mechanisms beyond the pulmonary veins (PVs) due to the underlying substrate. Here, I will investigate the differences in persistent AF mechanisms due to the underlying substrate and utilise these findings to generate AF mechanism specific ablation strategies. I have defined a new metric, rate-dependent conduction velocity (RDCV) slowing that has shown to correlate with sites of re-entry activity in AF. In this study, techniques and methods will be developed to measure RDCV slowing sites. The impact autonomic modulation has on AF mechanisms and CV dynamics will also be assessed. The hypothesis is that a combination of structural, electrical and autonomic remodelling play an important mechanistic role in persistent AF and ablation strategies adapted to target these will result in greater procedural success rate. The study findings have the potential to improve the success rate of catheter ablation in persistent AF thereby improve patient wellbeing and reduce the cost burden of AF treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing catheter ablation for persistent AF (<24 months AF duration and no previous left atrial ablation).

Able to provide informed consent

Disqualifiers

Unwillingness to sign consent

Age <18 years

Contraindications for catheter ablation procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Substrate guided ablation

    Other intervention

    Ablation strategy implemented will be dependent on the Arm the patient has been allocated to based on the presence of underlying LVZs.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Patients with underlying LVZs (≥30% of LVZs in the LA body)Experimental treatment 1 intervention
Group B: Patients without underlying LVZs (<30% of LVZs in the LA body)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sequential rate dependent conduction velocity (RDCV) assessment

RDCV slowing sites can be effectively identified prospectively using pacing protocols and multipolar catheters that are applicable to those routinely used in conventional ablation procedures.

Time frame
6 months
2

Ablation of RDCV slowing results in an positive ablation response.

RDCV slowing sites are mechanistically important in driving AF in patients with underlying LVZs. This will be measured through the impact ablation of RDCV slowing sites has on electrophysiological endpoints. RDCV slowing sites will be ablated and the proportion of these sites that results in a positive ablation response i.e. termination of AF into sinus rhythm or slowing of AF cycle length will be measured.

Time frame
6 months
3

Autonomic modulation impacts on conduction velocity measurements.

Autonomic modulation impacts conduction velocity (CV) measurements in patients with underlying LVZs. This will be measured through the impact autonomic modulation with Isoprenaline has on CV by comparing CVs measurements obtained post autonomic modulation to CVs measurements pre autonomic modulation.

Time frame
6 months
4

Autonomic modulation impacts on conduction velocity measurements.

Autonomic modulation impacts conduction velocity (CV) measurements in patients with underlying LVZs. This will be measured through the impact autonomic modulation by ganglionated plexi stimulation has on CV by comparing CVs measurements obtained post autonomic modulation to CVs measurements pre autonomic modulation.

Time frame
6 months

Secondary outcomes

1

RDCV slowing sites and GP sites identification on cardiac MRI

Cardiac MRI can be effectively used to identify RDCV slowing sites and GP sites whereby cardiac MRI can be used to pre procedure to target mapping and ablation more efficiently.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barts & The London NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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