What this study is
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.
What's being tested
- Remapping Procedure
Intervention · DEVICE
Remapping procedure with LAAO Implant with or without additional ablation.
Study details
- Sponsor
- Northwell Health
- Conditions
- Atrial Fibrillation (AF)
- Enrolling
- 50 people
- Starts
- 2026-05-01
- Est. completion
- 2028-07
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 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
You can't join 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSouth Shore University Hospital
Bay Shore, New York, United States
- Jason Chinitz, MD · Contact631-968-3016jchinitz@northwell.edu
- Rachel Gentles · Contact6319683016rgentles1@northwell.edu
- Jason Chinitz, MD · Principal investigator
Recruiting
Study team
Sponsor
Northwell Health
Study ID 25-1100
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.