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NCT Number: NCT05921734

A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint 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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Cathter Ablation Endpoint Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mu Qin, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . 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.

Exclusion criteria

  • . 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.

Treatment and study plan

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.

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.

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

    Time frame: Time Frame: 12 months

    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

Secondary outcomes

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

    Time frame: Time Frame: 12 months

    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

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

    Time frame: Time Frame: 12 months

    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

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

    Time frame: Time Frame: 12 months

    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

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

    Time frame: Time Frame: 12 months

    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

  5. procedural details

    Time frame: Time Frame: 12 months

    All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.

  6. incidence of periprocedural adverse events

    Time frame: Time Frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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