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

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Trial Information

Current as of December 31, 2024

Recruiting

Keywords

Pfa Pe Af Pfa/Rf

ClinConnect Summary

This clinical trial is studying a new treatment for patients with persistent atrial fibrillation (PeAF), which is a heart condition that causes an irregular heartbeat. The trial will involve 10 patients who will receive either a combined treatment using two types of catheters (PFA and RFA) or just the PFA catheter alone. The goal is to see how well these treatments work for patients who have not had success with other heart medications. Participants will be followed up at 1 month and 3 months after the treatment to monitor their progress.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of symptomatic persistent atrial fibrillation lasting more than 7 days but less than 1 year. They should also have tried at least one heart medication that didn’t work or was too difficult to tolerate. However, there are some health conditions that would exclude someone from participating, such as previous heart surgeries or certain heart-related issues. If you or a family member are interested in this trial, it’s important to discuss it with your doctor, who can provide more information about eligibility and what to expect from participation.

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 Shanghai Microport Ep Medtech Co., Ltd.

Shanghai MicroPort EP Medtech Co., Ltd. is a leading innovator in the field of electrophysiology and cardiac intervention, specializing in the development and manufacturing of advanced medical devices for the diagnosis and treatment of arrhythmias. Committed to enhancing patient outcomes through cutting-edge technology, the company focuses on research and development, clinical trials, and regulatory compliance to bring safe and effective solutions to healthcare professionals worldwide. With a strong emphasis on collaboration and quality, MicroPort EP Medtech aims to improve the lives of patients suffering from cardiovascular diseases through its innovative product offerings and comprehensive support services.

Locations

Chengdu, Sichuan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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