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

NCT07620262 | Recruiting DMC FDA Device

• 1 other identifier: 25-1100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Ablation; Atrial Fibrilation; Re-mapping; LAAO Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation

  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.

  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.

  From enrollment/index ablation to the 12month follow up post remapping procedure

Study Arms (1)

Single-arm, open label - all enrolled subjects

EXPERIMENTAL

Remapping procedure with LAAO Implant with or without additional ablation.

Device: Remapping Procedure

Interventions

Remapping Procedure DEVICE

Remapping procedure with LAAO Implant with or without additional ablation.

Single-arm, open label - all enrolled subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

South Shore University Hospital

Bay Shore, New York, 11706, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, open label

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)