A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation

A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint Versus Prespecified Ablation Strategy Followed by Cardioversion in Patients With Persistent Atrial Fibrillation

This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Cathter Ablation; Endpoint
• Intervention / Treatment: Procedure: AF-termination Group; Procedure: Prespecified-ablation Group

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital
  • Shanghai, China, 200030
    • Mu Qin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. . Age 18-80 years old.
2. . Patients undergoing a first-time ablation procedure for PersAF.
3. . Diagnosed as persistent AF according to the latest clinical guidelines.
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.

Exclusion Criteria:

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

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: AF-termination Group; Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.
Active Comparator: Prespecified-ablation Group	Procedure: Prespecified-ablation Group; Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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	All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
freedom from AF/AT after a single procedure without AADs (excludes the blanking period)	All patients included in the study had no incidence of AF/AT after a single procedure without AADs at 12 months after ablation excluding the initial 3-month blank period	Time Frame: 12 months
freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)	All patients included in the study had no incidence of freedom from AF/AT after a single procedure with or without anti-arrhythmic medications at 12 months after ablation excluding the initial 3-month blank period	Time Frame: 12 months
any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment	All patients included in the study had no incidence of any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months
freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure	All patients included in the study had no incidence of any AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period	Time Frame: 12 months
procedural details	All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.	Time Frame: 12 months
incidence of periprocedural adverse events	All patients' periprocedural adverse events including：ascular- significant groin，haematoma, pseudoaneurysm, AV fistula，Cardiac perforation，Pericardial effusion/ tamponade，Pericarditis，Pneumothorax/ haemothorax，Phrenic nerve injury，Periprocedural cerebrovascular accident - including air embolism，Esophageal injury - perforation / atrio-esophageal fistula，Pulmonary vein stenosis，Major bleeding event -including retroperitoneal bleeding，Heart block，Death	Time Frame: 12 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: CAPT-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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