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

NCT07577544 | Not Yet Recruiting

• 1 other identifier: B2025-700
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Acute Procedural Success of Mitral Isthmus Isolation

  The percentage of patients achieving acute bidirectional conduction block across the mitral isthmus (MI) line. Bidirectional block is confirmed using differential pacing techniques from the left atrial appendage and the distal coronary sinus after completing both endocardial and intra-coronary sinus pulsed field ablation

  Intraoperative (immediately following the ablation procedure)

Interventions

Focal Pulsed Field Ablation of the Coronary Sinus PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 30 consecutive participants who underwent catheter ablation for atrial fibrillation at Zhongshan Hospital, Fudan University. This cohort includes: * Clinical Presentation: The group is composed of paroxysmal atrial fibrillation and persistent atrial fibrillation. * Age Profile: All participants are between 18 and 75 years of age. * Treatment Context: Every patient in this population required substrate modification involving linear ablation at the mitral isthmus (MI) and within the coronary sinus (CS). * Health Status: The population excludes individuals with severe heart failure (NYHA Class III or IV), advanced renal failure eGFR\<30mL/min/1.73m²), or a history of heart surgery and left atrial appendage occlusion

You may qualify if:

• Symptomatic Atrial Fibrillation: participants must have a diagnosis of symptomatic paroxysmal or persistent atrial fibrillation.
• Documentation: The arrhythmia must be documented by electrocardiogram or Holter monitoring.
• Age Range: participants must be between 18 and 75 years of age.
• Study Compliance: participants must be willing and able to comply with the post-procedural follow-up schedule.
• Procedural Requirement: All patients must be candidates for linear ablation at the mitral isthmus (MI) and coronary sinus (CS) for substrate modification.

You may not qualify if:

• Prior Cardiac Procedures: Patients with a history of prior heart surgery or Left Atrial Appendage Occlusion (LAAO) are excluded.
• Heart Failure Severity: Individuals classified with New York Heart Association (NYHA) functional class III or IV are ineligible.
• Renal Impairment: Patients with advanced renal failure, defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m², are excluded.
• Intracardiac Thrombus: Any patient with a left atrial thrombus identified via transesophageal echocardiography (TEE) is excluded.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04