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NCT07064616Recruiting

Pulsed Field Ablation vs. Cryoballoon Ablation in Patients With Persistent Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
5 Jul 2025
Start date
25 Jun 2025
Primary completion date
31 Dec 2027
Lead sponsor
Kitasato University
NCT number
NCT07064616

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 25 Jun 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Paroxysmal or long-standing persistent AF (duration \>1 year)

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kitasato University School of Medicine
Coordinator of this site? Confirm its status
SagamiharaJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.