Search / Trial NCT06232798

A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jan 30, 2024

Trial Information

Current as of October 04, 2024

Recruiting

Keywords

Pfa Pe Af Pfa/Rf

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Aged 18-75 years old;
  • 2. Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year;
  • 3. Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
  • 4. Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.
  • Exclusion Criteria:
  • 1. Patients who have undergone left atrial surgery
  • 2. Left atrial thrombosis
  • 3. Patients with combined atrial tachycardia and atypical atrial flutter
  • 4. Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
  • 5. Anterior and posterior left atrial diameter ≥ 55mm
  • 6. Left ventricular ejection fraction (LVEF) ≤ 40%
  • 7. Previous atrial septal repair or atrial mucinous tumor
  • 8. Active implants (e.g. pacemakers, ICDs, etc.) in the body
  • 9. NYHA class III-IV cardiac function
  • 10. Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
  • 11. Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
  • 12. Those with acute or severe systemic infections
  • 13. Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
  • 14. Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
  • 15. Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
  • 16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Chengdu, Sichuan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0