Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation [CEASE AF - Trial]

Recruiting

• Conditions: fibrillation; 10007521; atrial fibrillation

• Registration Number: NL-OMON42344
• Lead Sponsor: AtriCure Europe B.V.

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: 60

Inclusion Criteria

Patients with Persistent and Longstanding Persistent Atrial Fibrillation
Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)

Exclusion Criteria

1. Patient has longstanding persistent AF > 10 years
2. Patient presenting with paroxysmal AF
3. Patient with persistent AF and a LA-diameter <= 4cm
4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible
or non-cardiovascular cause

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Effectiveness Endpoint is freedom from documented AF/AFL/AT<br /><br>episodes > 30 seconds through 12 months follow-up, in the absence of Class I or<br /><br>III AADs (with the exception of previously failed AADs at doses not exceeding<br /><br>those previously failed).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Secondary Effectiveness Endpoint is freedom from documented AF/AFL/AT) >30<br /><br>seconds through 24 and 36 months follow-up, in the absence of Class I or III<br /><br>AADs (with the exception of previously failed AADs at doses not exceeding those<br /><br>previously failed).<br /><br>The rhythm status used for evaluation of the Primary and Secondary Endpoint<br /><br>will be derived from regularly scheduled 48-hour Holter monitoring and any<br /><br>symptom driven monitoring performed.</p><br>