European CURE AF study, Concomitant Uitlization of Radiofrequency Energy for Atrail Fibrillatio

Withdrawn

• Conditions: heart rhythm disease; irregular heart rhythm; 10007521

• Registration Number: NL-OMON33162
• Lead Sponsor: Medtronic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1 Documented history of AF
2 Concomitant indication (other than AF) for open-heart surgery
3 Able to take the anticoagulant warfarin
4 Greater than or equal to 18 years of age;
5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.

Exclusion Criteria

1 NYHA functional class = IV,
2 Left ventricular ejection fraction < 30%,
3 Left atrial diameter > 7.0 cm,
4 Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery,
5 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure,
6 Pregnancy or desire to be pregnant within 12-months of the study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Occurrence of AF after ablation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Use of antiarrhythmic medication and antithromboembolic mediaction after<br /><br>ablation.</p><br>