PerAF: AF Termination vs Prespecified Ablation

Last updated: February 19, 2025
Sponsor: Shanghai Chest Hospital
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Dysrhythmia

Treatment

Atrial Fibrillation Termination

Prespecified Ablation

Clinical Study ID

NCT06837441
TPAF
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The design of this study is an intervention, randomized, controlled study and contains two randomized groups:(1)AF-termination group;(2)Prespecified-ablation group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. aged between 18 and 80 years old;

  2. Patients undergoing a first-time ablation procedure for PersAF, and in spontaneousAF at the beginning of the procedure;

  3. Diagnosed as persistent AF according to the latest clinical guidelines,with atrialfibrillation lasting for at least one month;

  4. Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment;

  5. Patients must be able and willing to provide written informed consent to participatein this study;

  6. Patients must be willing and able to comply with all study follow- up requirements.

Exclusion

Exclusion Criteria:

  1. .Uncontrolled congestive heart failure, EF <35%;

  2. . History of severe valve disease and/or prosthetic valve replacement;

  3. . Myocardial infarction or stroke within 6 months;

  4. . Severe congenital heart disease;

  5. . Left atrial diameter ≥60mm;

  6. . Contrast agent allergy;

  7. . The use of anticoagulant drugs is contraindicated;

  8. . Severe lung disease;

  9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound;

  10. .Contraindications for cardiac catheterization;

  11. .Prior left atrial ablation (surgical or catheter);

  12. .Have performed any cardiac surgery within 2 months;

  13. .Poor general health;

  14. .Life expectancy < 12 months, including factors such as physical inability totolerate ablation or unstable disease conditions.-

Study Design

Total Participants: 195
Treatment Group(s): 2
Primary Treatment: Atrial Fibrillation Termination
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai,
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.