Pulsed Field Ablation in the Coronary Sinus: Feasibility... | NCT07577544

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

NCT07577544

Sponsor

Shanghai Zhongshan Hospital

Status

Not yet recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Atrial Fibrillation (AF)

Interventions

Focal Pulsed Field Ablation of the Coronary Sinus

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2026Estimated

Primary Completion Date

May 31, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 4, 2026

First Submission Date that Met QC Criteria

May 4, 2026

First Posted Date

May 11, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2026

Last Update Posted Date

May 13, 2026Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes