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

Part of paid clinical trials in Bay Shore, New York.

Sponsor
Northwell Health
Study ID
NCT07620262
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remapping Procedure — DEVICE
    Remapping procedure with LAAO Implant with or without additional ablation.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single-arm, open label - all enrolled subjects
    Remapping procedure with LAAO Implant with or without additional ablation.

Primary Outcome Measure

To prospectively assess durability of PFA ablation [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
South Shore University HospitalBay ShoreNew York11706
Rachel Gentles
[email protected]
631-968-3016

Find similar trials in Bay Shore, NY

By research site
South Shore University Hospital· Bay Shore, NY

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