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Completed

NCT Number: NCT06837441

PerAF: AF Termination vs Prespecified Ablation

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Chest Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • .Uncontrolled congestive heart failure, EF <35%;
  • . History of severe valve disease and/or prosthetic valve replacement;
  • . Myocardial infarction or stroke within 6 months;
  • . Severe congenital heart disease;
  • . Left atrial diameter ≥60mm;
  • . 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, including factors such as physical inability to tolerate ablation or unstable disease conditions.-

Treatment and study plan

Atrial Fibrillation Termination

Procedure

Pursuing Atrial Fibrillation Termination as a Procedural Endpoint

Prespecified Ablation

Procedure

Prespecified Ablation Strategy Followed by Cardioversion

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, at a minimum of 12 months follow up after a single ablat

    Time frame: 12 months

Secondary outcomes

  1. Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months;

    Time frame: 12 months

  2. Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months

    Time frame: 12 months

  3. Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months

    Time frame: 12 months

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

    Time frame: 12 months

  5. Incidence of periprocedural adverse events.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • Jinshan Hospital Affiliated to Fudan University
  • The Shanghai Yangpu Central Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 20, 2025
Registry last updated
Feb 20, 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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