POLARx™ versus Arctic Front Advance™ Cryoablation Systems for Patients with Atrial Fibrillation.

A Dual-Centre Randomised Double-Blind Trial comparing the Arctic Front Advance™ Cryoballoon to the POLARx™ Cryoablation System for Pulmonary Vein Isolation in patients with Atrial Fibrillation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000003875

Enrollment

105

Registered

2021-01-07

Start date

2022-05-30

Completion date

2023-12-13

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

This is a dual centre, randomised, double blinded trial of two pulmonary vein isolation systems for paroxysmal AF. Participants will be screened from all participants referred for pulmonary vein isolation aged between 17 and 80 years. Randomisation will occur after consent is obtained and on enrolment into the study. Participants will be randomised to pulmonary vein isolation with the Arctic Front Advance™ Cryoballoon or the POLARx™ Cryoablation System. It is planned that 110 participants will be randomised in a 1:1 ratio to one of two treatment arms: • 55 will undergo pulmonary vein isolation via the Arctic Front Advance™ Cryoballoon. • 55 will undergo pulmonary vein isolation via the POLARx™ Cryoablation System. Primary non-inferiority endpoints • Total procedure time • Total ablation time Secondary safety and tolerability endpoints • Complications of Pulmonary Vein Isolation. • Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure). Secondary efficacy endpoints: • Burden of recurrent symptomatic documented AF episodes. • Burden of recurrent documented AF episodes. • Time to recurrence of AF. • Any symptomatic AF recurrence. • Hospitalisation.

Interventions

Cryoablation for atrial fibrillation with the POLARx™ Cryoablation System. Pulmonary vein isolation (PVI) will occur once during the trial following randomisation. PVI will take approximately 1-2 hours. This will be performed by a cardiac electrophysiologist.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

• Age between 17-80 years. • Have atrial fibrillation • Are referred for AF ablation after failure of at least one antiarrhythmic drug (AAD).

Exclusion criteria

• Pregnant or breastfeeding females. • Inability to provide informed consent. • Severe left atrial (LA) dilatation (>6cm in diameter) • Medical comorbidity where anticoagulation is contra-indicated. • Persistent atrial fibrillation for >1 year

Outcome results