PerAF: AF Termination vs Prespecified Ablation

Atrial Fibrillation Termination Versus Prespecified Ablation for Persistent Atrial Fibrillation:A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Atrial Fibrillation Termination; Procedure: Prespecified Ablation

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AF-termination group	Procedure: Atrial Fibrillation Termination; Pursuing Atrial Fibrillation Termination as a Procedural Endpoint
Sham Comparator: Prespecified-ablation group	Procedure: Prespecified Ablation; Prespecified Ablation Strategy Followed by Cardioversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；	12 months
Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months	12 months
Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months	12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure	12 months
Incidence of periprocedural adverse events.	12 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: The Shanghai Yangpu Central Hospital; Jinshan Hospital Affiliated to Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TPAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No