Menu
Recruiting NCT06157437

An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

No phase Interventional Typical Atrial Flutter Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal Pulse field Ablation.
Who it may be relevant to
Registry conditions: Typical Atrial Flutter, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.

Interventions

  • Device Focal Pulse field Ablation
    Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.

Primary outcome measures

  • Acute procedural success [Time frame: immediately after the procedure]
Secondary outcome measures (4)
  • Chronic success [Time frame: 6 months after procedure]
  • Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time [Time frame: immediately after the procedure]
  • Incidence of device-related major adverse events (MAE) within 7 days after ablation [Time frame: within 7 days after ablation]
  • Incidence of device-related severe adverse events (SAE) [Time frame: 3 months and 6 months after procedure]

Eligibility criteria

Inclusion criteria

  • Subjects aged at least 18;
  • Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
  • Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion criteria

  • Any prior cavo-tricuspid isthmus ablation;
  • Unstable angina;
  • Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
  • Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
  • At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
  • Implantable devices such as ICDs, CRTS and pacemakers in the body;
  • Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
  • Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
  • Previously received tricuspid metal valve replacement;
  • Thromboembolic events (including transient ischemic attacks) within the past 6 months;
  • Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
  • Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
  • Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
  • Acute systemic infection;
  • Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
  • Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
  • Enrollment in another clinical trial evaluating other devices or drugs during the same period;
  • Life expectancy less than 12 months (e.g. advanced malignancy);
  • Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06157437 · fPFA001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗