Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07106970

PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

Led by Boston Scientific Corporation · Updated on 2026-05-01

640

Participants Needed

1

Research Sites

139 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)

CONDITIONS

Official Title

PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • Have symptomatic, drug-resistant, persistent atrial fibrillation
  • Symptoms may include palpitations, presyncope, syncope, fatigue, or shortness of breath
  • Persistent atrial fibrillation continuous for more than 90 days confirmed by physician and ECG
  • Undergoing first-time ablation procedure for atrial fibrillation
  • Willing and able to provide informed consent and participate in all study tests
Not Eligible

You will not qualify if you...

  • Atrial fibrillation caused by electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
  • Left atrial diameter 6.0 cm or larger by echocardiography within 3 months before procedure
  • Heart failure with left ventricular ejection fraction below 30% within 3 months before procedure
  • Left atrial thrombus detected by imaging within one day before or during procedure
  • Presence of pacemaker, defibrillator, cardiac resynchronization device, mechanical valve, or closure devices at ablation
  • Myocardial infarction, unstable angina, coronary intervention, or cardiac surgery within 90 days before consent
  • Pericarditis or symptomatic pericardial effusion within 90 days before consent
  • Gastrointestinal bleeding within 90 days before consent
  • Stroke, transient ischemic attack, intracranial bleeding, or thromboembolic event within 90 days before consent
  • Cannot use or unwilling to use systemic anticoagulation
  • Cannot stop Class I/III antiarrhythmic drugs except for atrial arrhythmia
  • Pregnant or lactating women of childbearing potential
  • Severe kidney problems with low filtration rate, dialysis, or kidney transplant history
  • Any condition that interferes with study assessment or increases risk according to investigator
  • Life expectancy less than 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Anzhen Hospital, affiliated to Capital Medical University

Beijing, China, 101118

Actively Recruiting

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Research Team

T

Taimin Yue

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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