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

NCT07106970 | Recruiting

• 1 other identifier: PF336
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint with Treatment Success.

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

  Completion of treatment 360 days compared with the baseline

• 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).

  Completion of treatment 360 days compared with the baseline

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint with Chronic Success.

  Completion of treatment 360 days compared with the baseline.

• Secondary Safety Endpoint with Non-SAE.

  Completion of treatment 360 days compared with the baseline

Study Arms (2)

PVI and linear ablation arm

EXPERIMENTAL

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

PVI alone arm

ACTIVE COMPARATOR

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

Procedure: PVI alone

Interventions

PVI alone PROCEDURE

Undergo PVI with the study device

PVI alone arm; PVI and linear ablation arm

Linear ablation PROCEDURE

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 and linear ablation arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with an age range of 18 years or above and 80 years or below.
• Subjects have symptomatic, drug-resistant, persistent AF, defined as:
• Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
• Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
• 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.
• Subjects undergoing a first-time ablation procedure for AF.
• Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

You may not qualify if:

• AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
• Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
• Heart failure with left ventricular ejection fraction (LVEF) \< 30% by TTE within 3 months prior the procedure.
• 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.
• 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.
• Any of the following events within 90 days of the Consent Date:
• Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
• Pericarditis or symptomatic pericardial effusion
• Gastrointestinal bleeding
• Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
• Contraindication to, or unwillingness to use systemic anticoagulation.
• Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
• Women of childbearing potential who are pregnant or lactating.
• 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.
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Beijing Anzhen Hospital, affiliated to Capital Medical University

Beijing, 101118, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Changsheng Ma, Doctor

  Beijing Anzhen Hospital of the Capital University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taimin Yue

CONTACT

86-10-8574 2988; taimin.yue@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The control group will consist of subjects randomized into PVI alone arm, who will accept bilateral PVI only with the same study device as those used in the Test group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 6, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)