Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study (PRECLUDE)

This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Device: Remapping Procedure

Detailed Description

Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.

The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • Recruiting
      • South Shore University Hospital
      • Contact: Rachel Gentles; Phone Number: 631-968-3016; Email: rgentles1@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant is ≥ 18 years of age, or older if specified by local law
• Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
• Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
• Participant has a CHADSVASc>=3
• There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
• Participant is willing and capable of providing informed consent
• Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria:

• Participant has had prior AF ablation (including surgical ablation)
• Participant has had prior left atrial appendage occlusion or closure
• Participant has an intracardiac mass or thrombus
• Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
• Participant has a life expectancy < 1 year
• Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
• Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits Participant has an active systemic infection
• Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis
• Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
• Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
• Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-arm, open label - all enrolled subjects; Remapping procedure with LAAO Implant with or without additional ablation.	Device: Remapping Procedure; Remapping procedure with LAAO Implant with or without additional ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To prospectively assess durability of PFA ablation	Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure).	From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation	Patients demonstrating durable PVI (+/- posterior wall isolation) confirmed during remapping procedure will be monitored for arrhythmia recurrence. Arrhythmia recurrence will be evaluated based on 1-week extended Holter monitoring performed at 6 months and 12 months post ablation.	6 months and 12 months post remapping procedure
Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.	Clinical outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of clinical AT/AF recurrence and symptomatic arrhythmia recurrence.	From enrollment/index ablation to the 12month follow up post remapping procedure
Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.	Procedural related outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of ischemic stroke/TIA, bleeding complications, hospitalizations, and death.	From enrollment/index ablation to the 12month follow up post remapping procedure

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ablation; Atrial Fibrilation; Re-mapping; LAAO Device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 25-1100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes