Persistent Atrial Fibrillation
Conditions
Keywords
Pulsed-field ablation, Cryoballoon ablation
Brief summary
This clinical study is being conducted to compare two different treatment methods for persistent atrial fibrillation (AF), a common heart rhythm disorder. Atrial fibrillation occurs when the upper chambers of the heart (the atria) beat rapidly and irregularly. This can lead to symptoms like palpitations, shortness of breath, or fatigue, and it increases the risk of stroke or heart failure. Persistent atrial fibrillation means that the irregular heart rhythm continues and does not stop on its own. Treatment often includes a procedure called catheter ablation, where special instruments are used to create small scars in the heart to block the abnormal electrical signals causing the arrhythmia. Currently, two main types of catheter ablation are used in Japan: Cryoballoon Ablation: A technique that uses extreme cold to create scars and isolate the pulmonary veins, which are often the source of the irregular signals. Pulsed Field Ablation (PFA): A newer technique that uses very short bursts of electrical energy to target the heart tissue, with the aim of reducing damage to surrounding structures. While pulsed field ablation has been introduced in Japan recently and seems to be safe, there is limited data about how well it works compared to cryoballoon ablation, especially in patients with persistent atrial fibrillation. This study aims to find out whether pulsed field ablation is as effective and safe as cryoballoon ablation for treating persistent AF.
Interventions
DEVICECatheter ablation using pulsed field ablation
PulseSelect™ Pulsed Field Ablation System: This intervention uses the PulseSelect™ system to perform pulsed field ablation (PFA) for pulmonary vein isolation in patients with persistent atrial fibrillation. PFA delivers short, high-voltage electrical pulses that selectively affect myocardial cells while minimizing damage to surrounding tissues such as the esophagus or phrenic nerve. This technique is designed to reduce procedural complications and improve safety compared to traditional thermal ablation methods.
DEVICECatheter ablation using cryoballoon ablation
Cryoballoon Ablation: This intervention uses a cryoballoon catheter to perform pulmonary vein isolation by freezing tissue around the pulmonary veins. The balloon delivers extreme cold temperatures to create transmural lesions that block abnormal electrical signals responsible for atrial fibrillation. Cryoballoon ablation is widely used and considered effective for atrial fibrillation treatment but may carry risks related to collateral tissue injury.
Sponsors
Nerima Hikarigaoka Hospital
Sagamihara Kyodo Hospital
Kitasato University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 85 years * Diagnosed with PeAF (lasting less than one year or requiring cardioversion) * Eligible for catheter ablation according to current Japanese guidelines * Provided written informed consent
Exclusion criteria
* Paroxysmal or long-standing persistent AF (duration \>1 year)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial fibrillation recurrence at 12 months | 12 months post-procedure | Proportion of patients without documented atrial fibrillation lasting 30 seconds or longer after a 3-month blanking period following the ablation procedure, assessed by ECG or Holter monitoring. |
Countries
Japan
Contacts
Primary ContactHidehira Fukaya, MD, PhD
Outcome results
None listed