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PerAF: AF Termination vs Prespecified Ablation

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Persistent Atrial Fibrillation

Treatments

Procedure: Atrial Fibrillation Termination
Procedure: Prespecified Ablation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

195 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. aged between 18 and 80 years old;
  2. Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;
  3. Diagnosed as persistent AF according to the latest clinical guidelines,with atrial fibrillation 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 participate in this study;
  6. Patients must be willing and able to comply with all study follow- up requirements.

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 to tolerate ablation or unstable disease conditions.-

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

195 participants in 2 patient groups

AF-termination group
Experimental group
Treatment:
Procedure: Atrial Fibrillation Termination
Prespecified-ablation group
Sham Comparator group
Treatment:
Procedure: Prespecified Ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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