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RecruitingNCT07106970Updated Sep 29, 2026

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

An interventional study of Linear ablation and PVI alone in Persistent Atrial Fibrillation, sponsored by Boston Scientific Corporation. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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)

Read the detailed description

This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.

02

Conditions studied

  • Persistent Atrial Fibrillation

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Study subjects are required to meet all the following inclusion criteria:

  1. Subjects with an age range of 18 years or above and 80 years or below.
  2. Subjects have symptomatic, drug-resistant, persistent AF, defined as:

    1. Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
    2. Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
    3. Persistent: continuous AF for > 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
  3. Subjects undergoing a first-time ablation procedure for AF.
  4. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion criteria

Exclusion Criteria:

  1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
  2. Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
  3. Heart failure with left ventricular ejection fraction (LVEF) \< 30% by TTE within 3 months prior the procedure.
  4. LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
  5. Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
  6. Any of the following events within 90 days of the Consent Date:

    1. Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
    2. Pericarditis or symptomatic pericardial effusion
    3. Gastrointestinal bleeding
    4. Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
  7. Contraindication to, or unwillingness to use systemic anticoagulation.
  8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
  9. Women of childbearing potential who are pregnant or lactating.
  10. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
  11. Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
  12. Predicted life expectancy less than 12 months.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
640 participants (estimated)

Study arms

  • Experimental
    PVI and linear ablation arm

    Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device, and EIVOM could be performed additionally before or after PFA at the operator's discretion.

    Procedure: Linear ablation · Procedure: PVI alone

  • Active comparator
    PVI alone arm

    Subjects randomized to the PVI alone arm will undergo PVI only with the study device.

    Procedure: PVI alone

Interventions

  • ProcedureLinear ablation

    Linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.

  • ProcedurePVI alone

    Undergo PVI with the study device

05

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint with Treatment Success.

    Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.

    Time frame: Completion of treatment 360 days compared with the baseline

  2. Primary Safety Endpoint with Safety events related to AF catheter ablation.

    Number of Participants with following device or procedure-related serious Composite Adverse Events (CAEs).

    Time frame: Completion of treatment 360 days compared with the baseline

Secondary outcomes

  1. Secondary Effectiveness Endpoint with Chronic Success.

    Number of Participants with Chronic Success, Freedom from any documented AF, AFL or AT episode lasting ≥10s via 12-lead ECG or ≥30s via Holter (or other continuous rhythm monitoring device) on/off AADs after the blanking period to Day 360.

    Time frame: Completion of treatment 360 days compared with the baseline.

  2. Secondary Safety Endpoint with Non-SAE.

    Number of Participants with Non-Serious Composite Adverse Event

    Time frame: Completion of treatment 360 days compared with the baseline

06

Study locations

1 of 1 sites recruiting
  • Beijing Anzhen Hospital, affiliated to Capital Medical University
    Beijing, 101118, China
    • Caihua Sang, Doctor · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07106970
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Aug 28, 2025
Primary completion
Dec 30, 2027 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Taimin Yue
Contact
taimin.yue@bsci.com
86-10-8574 2988
Changsheng Ma, Doctor
principal investigator · Beijing Anzhen Hospital of the Capital University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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