NCT07620262Recruiting
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 May 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Northwell Health
- Diseases
- Atrial fibrillation
- NCT number
- NCT07620262
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 May 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has had prior AF ablation (including surgical ablation)
- Participant has had prior left atrial appendage occlusion or closure
Other illness
- Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
- 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 had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
Other
- Participant has an intracardiac mass or thrombus
- Participant has a life expectancy \< 1 year
- Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Shore University Hospital Coordinator of this site? Confirm its status | Bay Shore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.