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Cryoballoon ablation compared with single ring radiofrequency ablation for the treatment of atrial fibrillation: The Hot and Cold Study

In patients with paroxysmal atrial fibrillation not controlled on medical therapy, does single ring pulmonary vein isolation, compared with cryoballoon ablation, lead to reductions in recurrence of atrial tachyarrythmias.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000967583
Enrollment
6
Registered
2015-09-16
Start date
2016-01-27
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Atrial fibrillation (AF) is the most common heart rhythm disorder and develops in 20-25% of people over their lifetime. The initial treatment has been medication therapy, however in the past decade, a catheter ablation procedure called pulmonary vein isolation has become increasingly widely practiced and is more effective than medical therapy at treating AF. This is performed by introducing catheters via the groin veins to the heart. There are two methods available in Australia for performing this procedure which aims to electrically isolate the pulmonary veins from the rest of the left atrium to which they connect in the heart as these usually contain abnormal foci that trigger the initiation of AF. The first of the two methods utilises radiofrequency ablation to create burns to the inside of the left atrium to encircle the pulmonary veins and the back wall of the left atrium. From a recent randomised clinical trial, we have found that the use of a large single ring was better than the conventional two separate rings in preventing the recurrence of AF. The second method uses more recent technology and involves a cryoballoon catheter that freezes the tissues around the pulmonary veins to achieve the same effect. Recent studies of this technique has shown it to be a safe and effective means of performing pulmonary vein isolation. It is not known which of the two procedures is more effective. We aim in the present randomised controlled clinical trial to investigate the relative efficacy and safety of the two procedures.

Interventions

Cryoablation will be performed using the Arctic Front device (Medtronic, St Paul, MN, USA) and Enquiry mapping catheter. This device is inflated within each vein orifice. The current recommended approach is to perform two 4 minute inflations within each pulmonary vein with additional freezes if electrical isolation has not been achieved. A 28mm balloon will be used where possible. The procedural end point will be durable (>30minutes) electrical isolation of all pulmonary veins.

Sponsors

Stuart Thomas
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Symptomatic paroxysmal atrial fibrillation with an indication for pulmonary vein isolation

Exclusion criteria

Less than 18 yrs of age. Unable to provide informed consent. Undergone previous left atrial surgical or ablation procedures for atrial fibrillation. Contraindications to cryoballoon ablation or radiofrequency ablation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026