Defining the BURden after surgical ablation therapY for the treatment of Atrial Fibrillatio

Recruiting

• Conditions: Atrial fibrillation; 10007521

• Registration Number: NL-OMON47756
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

-(Longstanding) persisterend or paroxysmal AF
-Accepted for thoracoscopic surgical ablation (TT-maze or port-access
concomitant left atrial MAZE surgery (heartport))
-18 years or older
- The patient is mentally able and willing to give informed consent
- The patient agrees with the implantation of an implantable loop recorder

Exclusion Criteria

No ILR implantation prior to surgery

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is:<br /><br>- to evaluate the burden of AF and quality of life rhythm after thoracoscopic<br /><br>ablation surgery and after port-access concomitant left atrial MAZE surgery by<br /><br>continuous rhythm monitoring (Medtronic Reveal Linq Insertable Cardiac<br /><br>Monitor*).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are:<br /><br>- to evaluate freedom from AF/AFl/AT,<br /><br>- to assess the clinical safety of the procedure<br /><br>- to assess neurologic outcome (ischemic stroke, hemorrhagic stroke, transient<br /><br>ischemic attack)<br /><br>- to evaluate the postoperative biochemical cardio-inflammatory response<br /><br>(NT-pro-BNP, CRP, IL-6 and troponin levels) </p><br>