Recruiting

Pulsed Field Ablation

Sponsor:

Northwell Health

Code:

NCT07620262

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remapping Procedure

Study Details

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)

Study ID

NCT07620262

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 in women and >=2 in men
  • 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
  • Participant has longstanding persistent AF ongoing for greater than 10 years
  • Participant has Left atrial appendage anatomy unsuitable for LAAO device
  • Participant has an LA diameter >6 cm

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-arm, open label - all enrolled subjects

Remapping procedure with LAAO Implant with or without additional ablation.

Interventions

Remapping Procedure

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. ]

Central Contacts and Locations

Locations

South Shore University Hospital

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Rachel Gentles

631-968-3016rgentles1@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jul 17, 2026

Last verified

May, 2026

Keywords

  • Ablation
  • Atrial Fibrilation
  • Re-mapping
  • LAAO Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-07-17.