PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
NCT ID: NCT07106970
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
640 participants
INTERVENTIONAL
2025-08-28
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Linear 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.
PVI alone
Undergo PVI with the study device
PVI alone arm
Subjects randomized to the PVI alone arm will undergo PVI only with the study device.
PVI alone
Undergo PVI with the study device
Interventions
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Linear 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.
PVI alone
Undergo PVI with the study device
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Changsheng Ma, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Locations
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Beijing Anzhen Hospital, affiliated to Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Caihua Sang, Doctor
Role: primary
Other Identifiers
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PF336
Identifier Type: -
Identifier Source: org_study_id