Pulsed-field ablation vs radio-frequency ablation for recurrent atrial fibrillation.

Comparing rates of acute posterior wall isolation in patients undergoing repeat atrial fibrillation ablation using pulsed-field vs radiofrequency ablation.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001306505

Enrollment

120

Registered

2024-10-28

Start date

2024-11-25

Completion date

2025-12-31

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

It is hypothesed that pulsed-field ablation will result in better acute procedural outcomes than radiofrequency ablation. This is a multi-centre, randomised control trial of two ablations systems for atrial fibrillation. Participants referred for repeat AF ablation will be screened and randomised to repeat atrial fibrillation with pulsed-field ablation or radiofrequency ablation. The primary outcome is acute posterior wall isolation. The secondary outcomes include acute pulmonary vein isolation, AF recurrence as assessed by 3 and 12-month Holter monitor, left atrial (LA) physiology and procedural metrics.

Interventions

Elective repeat AF ablation with pulsed field technology Patients with recurrent AF in this arm will be treated with pulsed-field ablation using the Farapulse system from Boston Scientific. Patients will undergo isolation of the pulmonary veins and posterior wall using the Farawave ablation catheter. The number of applications during the procedure and dose is pre-specified/as per manufacturer recommendations (2Hz, 4 applications in "flower" configuration, 4 applications in "basket" configuration per pulmonary vein; however, further applications can be delivered as the discretion of the operator). This is performed by an electrophysiologist. There is only 1 session (the procedure). Each session is approximately 2-3 hours

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

• Age between 18-80 years • Paroxysmal or persistent atrial fibrillation (persistent AF < 3 years) • Referred for a repeat atrial fibrillation ablation (AFA) following an AF recurrence which has occurred more than 6 weeks after previous AFA, provided the only ablation preformed was pulmonary vein isolation (PVI) ) +/- cavo-tricuspid isthmus (CTI) line. Ablation techniques employed in previous AFA can be radiofrequency ablation (RFA), pulsed-field ablation (PFA) or cyoballoon ablation (CBA).

Exclusion criteria

• Persistent AF > 3 years • Patient with previous AFA which involved non-pulmonary vein (PV) targets such as left atrial posterior wall isolation, mitral isthmus line, superior vena cava (SVC) isolation, atypical atrial flutter lines) • Pregnant or breastfeeding females. • Inability to provide informed consent. • Medical comorbidity where anticoagulation is contra-indicated.

Outcome results