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Pulsed Field Ablation in the Coronary Sinus: Feasibility and Safety of a Novel Approach for Mitral Isthmus Block

NCT07577544 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-05-13

No results posted yet for this study

Summary

Why This Study Is Important

* Many patients with atrial fibrillation (AF) continue to experience abnormal heart rhythms even after receiving standard treatments.
* Standard heat-based energy can be difficult to use in these areas because fast blood flow cools the tissue, and excessive heat may damage nearby structures like the right coronary artery.

Our Approach

* Investigators are testing a newer technology called pulsed field ablation (PFA).
* Unlike traditional methods, PFA uses ultra-short electrical pulses rather than heat to target heart cells specifically while protecting neighboring nerves and blood vessels.
* This study focuses on applying this energy within the coronary sinus to help achieve a more complete and lasting electrical block for the mitral isthmus.

What To Expect

* This study involves 30 participants who are already undergoing a catheter ablation procedure for atrial fibrillation.
* The research team will monitor how successful the procedure is at immediately stopping the abnormal electrical signals.
* Participants will have follow-up visits over six months to check for any returning heart rhythm issues and will receive a specialized heart scan (CTA) to ensure the nearby coronary arteries remain healthy

Conditions

  • Atrial Fibrillation (AF)

Interventions

PROCEDURE

Focal Pulsed Field Ablation of the Coronary Sinus

This study utilizes focal pulsed-field ablation (PFA) specifically targeting the coronary sinus (CS) to achieve permanent electrical isolation of the mitral isthmus (MI). Unlike traditional radiofrequency ablation, this intervention delivers non-thermal, ultra-short high-voltage pulses that induce irreversible electroporation specifically in myocardial cells

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-05-31
Completion
2026-06-30

More Related Trials

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 NCT07577544 on ClinicalTrials.gov