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

9. maj 2026 opdateret af: Shanghai Zhongshan Hospital

Safety, Efficacy and Mid-term Outcomes of Pulsed Field Ablation for Mitral Isthmus Ablation Through Epicardial Approach

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Procedural Success of Mitral Isthmus Isolation
Tidsramme: Intraoperative (immediately following the ablation procedure)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

31. maj 2026

Studieafslutning (Anslået)

30. juni 2026

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • B2025-700 (Sun Yat-sen University Cancer Center)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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