Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Northwell Health
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.
Description
Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal ele…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * 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 wi…
Interventions
- DeviceRemapping Procedure
Remapping procedure with LAAO Implant with or without additional ablation.
Location
- South Shore University HospitalBay Shore, New York