Pulmonary Vein Isolation (PVI) versus PVI plus Selective Ablation of Low VoltagE Areas for Persistent Atrial Fibrillation (SOLVE-AF) – A Randomized Multi-Center Trial

Not Applicable

Recruiting

• Conditions: I48.1; Persistent atrial fibrillation

• Registration Number: DRKS00010429
• Lead Sponsor: niversitäts-Herzzentrum Freiburg-Bad Krozingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Age =18 years and <80 years
2. Eligibility for first ablation procedure for symptomatic persistent AF (>7days and <12 months longest AF duration)
3. Written informed consent obtained according to international guidelines and local laws
4. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion Criteria

1. Previous ablation for AF
2. Contra-indications for AF catheter ablation therapy (thrombus in left atrium (LA), at TEE high risk for bleeding under anticoagulant therapy, short life expectancy)
3. Patients with paroxysmal AF (<7 days persisting)
4. Patients with long standing AF (>12 months)
5. LA diameter >55 mm
6. Hyperthyroidism
7. Heart failure, NYHA 3 and 4
8. Valvular AF (Mitral or aortic valvulopathy >Grade 2/3)
9. Other major disabling disease
10. Current pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Single-procedural freedom of atrial fibrillation (AF) and atrial tachycardia/ flutter (AT) without antiarrhythmic drug treatment within 12 months after the first ablation<br>procedure.<br>