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3D-Guided Pulsed Field Ablation for Paroxysmal AF

NCT07023237 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 430

Last updated 2025-06-15

No results posted yet for this study

Summary

Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure. In China, AF affects approximately 20 million adults, and its prevalence is expected to rise due to aging \[1, 2\]. Catheter ablation has become a first-line treatment for AF, with pulsed field ablation (PFA) gaining attention due to its tissue selectivity and non-thermal ablation properties \[3-8\]. PFA uses high-voltage electric fields to create cell membrane perforations, leading to permanent tissue damage and effective arrhythmia treatment \[6-8\].

Recent studies have shown that PFA is highly effective and safe. For example, the EU-PORIA study reported a 99.96% pulmonary vein isolation (PVI) rate with a 3.6% complication rate \[9, 10\], while the ADVENT study demonstrated similar efficacy to thermal ablation but with shorter procedure times \[12\]. However, current PFA systems often lack integration with 3D mapping systems, limiting their application in complex cases and increasing reliance on fluoroscopy \[13, 14\].

In China, domestic PFA technology is rapidly evolving, with a focus on expanding indications and integrating 3D techniques \[19, 20\]. The investigators have conducted preliminary studies on the feasibility and safety of domestic PFA in persistent AF treatment \[21\]. To further advance PFA, larger-scale clinical studies are needed to optimize procedural workflows and reduce complications.

This study aims to enroll 430 participants through a single-center, single-arm approach. By following up for one year, the investigators will optimize the PFA procedure under 3D guidance to enhance success rates and safety. This will support the clinical promotion of PFA technology and provide valuable data for the development of domestic PFA devices.

Conditions

  • Atrial Fibrillation (AF)
  • Pulsed Field Ablation

Interventions

PROCEDURE

pulsed field ablation

Pulsed electric fields refer to the generation of high-voltage electric fields with pulse widths ranging from milliseconds to microseconds or even nanoseconds. These fields release extremely high energy in a very short time, creating a large number of irreversible micropores in the cell membrane and even intracellular organelles such as the endoplasmic reticulum, mitochondria, and nucleus. This ultimately leads to apoptosis of the diseased cells, achieving the desired therapeutic effect. By inserting a pulsed ablation catheter into the patient's body and reaching the target lesion, the pulsed energy is delivered to the ablation catheter via a cardiac pulsed field ablation device, thereby achieving the therapeutic goal of pulsed field ablation.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-07-01
Completion
2026-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023237 on ClinicalTrials.gov