Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF)

Completed

Conditions: AF
atrial fibrillation
10007521

Registration Number: NL-OMON55237

Lead Sponsor: Medtronic BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

A diagnosis of recurrent symptomatic paroxysmal or persistent AF with failure
of at least one AAD (class I or III) for AF as evidenced by recurrent
symptomatic AF, or intolerable side effects due to AAD.

Exclusion Criteria

Long-standing persistent AF (continuous AF that is sustained >12 months)
Patient who is not on oral anticoagulation therapy for at least 3 weeks prior
to the ablation procedure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Protocol page 33:<br /><br><br /><br>Pilot Phase Safety Objective:<br /><br>Assess the incidence of PFA system-related and PFA procedure-related serious<br /><br>adverse events<br /><br>(SAEs) within 30 days post-ablation.<br /><br><br /><br>Pilot Phase Effectiveness Objective:<br /><br>Assess the acute procedural success of PVI ablation with the PFA system.<br /><br><br /><br><br /><br><br /><br>Pivotal Phase Primary Safety Objective:<br /><br>Demonstrate an acceptable safety profile of PVI ablation with the PFA system.<br /><br><br /><br>Pivotal Phase Primary Effectiveness Objective:<br /><br>Demonstrate an acceptable chronic effectiveness of PVI ablation with the PFA<br /><br>system, based on<br /><br>freedom from treatment failure.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Protocol page 33, 34:<br /><br><br /><br>Secondary Objective<br /><br>The following secondary objective will be reported separately by paroxysmal AF<br /><br>and persistent AF:<br /><br>1. Assess changes in quality of life from baseline through 12 months after the<br /><br>index ablation<br /><br>procedure.</p><br>