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Protocol for a prospective, multicenter, randomized, controlled trial comparing pulsed field ablation vs. cryoballoon

Hidehira Fukaya1, Jun Oikawa2, Tomoharu Yoshizawa3

  • 1Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.

International Journal of Cardiology. Heart & Vasculature
|October 23, 2025
PubMed
Abstract

Keywords:
Atrial fibrillationCatheter ablationCryoballoon ablationPulsed-field ablationRandomized controlled trial

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Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.