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

NCT05921734 | Completed

• 1 other identifier: CAPT-AF
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Atrial Fibrillation; Cathter Ablation; Endpoint

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• freedom from AF/AT after a single procedure without AADs (excludes the blanking period)

  Time Frame: 12 months

• freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)

  Time Frame: 12 months

• any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment

  Time Frame: 12 months

• freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure

  Time Frame: 12 months

• procedural details

  Time Frame: 12 months

Study Arms (2)

AF-termination Group

EXPERIMENTAL

Procedure: AF-termination Group

Prespecified-ablation Group

ACTIVE COMPARATOR

Procedure: Prespecified-ablation Group

Interventions

AF-termination Group PROCEDURE

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.

AF-termination Group

Prespecified-ablation Group PROCEDURE

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.

Prespecified-ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old.
• Patients undergoing a first-time ablation procedure for PersAF.
• Diagnosed as persistent AF according to the latest clinical guidelines.
• Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.
• Patients must be able and willing to provide written informed consent to participate in this study.

You may not qualify if:

• Uncontrolled congestive heart failure;
• History of severe valve disease and/or prosthetic valve replacement;
• Myocardial infarction or stroke within 6 months;
• Severe congenital heart disease;
• EF \<35%;
• Contrast agent allergy;
• The use of anticoagulant drugs is contraindicated;
• Severe lung disease;
• Left atrial thrombus confirmed by preoperative esophageal ultrasound;
• Contraindications for cardiac catheterization;
• Prior left atrial ablation (surgical or catheter);
• Have performed any cardiac surgery within 2 months;
• Poor general health;
• Life expectancy \< 12 months.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (2)

Mu Qin

Shanghai, 200030, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 27, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2023-06

Locations

CN (2)