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

Overview

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.

Detailed 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 electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.

The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.

Interventions

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

Primary outcome measures

• 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.]

Secondary outcome measures (3)

• To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation [Time frame: 6 months and 12 months post remapping procedure]
• Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures. [Time frame: From enrollment/index ablation to the 12month follow up post remapping procedure]
• Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures. [Time frame: From enrollment/index ablation to the 12month follow up post remapping procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• South Shore University Hospital — Bay Shore

Identifiers

NCT: NCT07620262 · 25-1100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗