Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillatio

Recruiting

Conditions: Atrial fibrillation
supraventricular arrythmia
10007521

Registration Number: NL-OMON48892

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

- Age is between 18 and 80 years.
- Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1)
ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
- AF documented by ECG or Holter < 1 year ago.
- At least one class I or III anti-arrhythmic drug in standard dosage has
failed or is not tolerated.
- Left atrial volume index <40 ml/m2

Exclusion Criteria

- Prior intervention (catheter ablation or minimally-invasive thoracoscopic
ablation) for AF.
- AF is secondary to electrolyte imbalance, thyroid disease or other reversible
or non-cardiovascular causes.
- Paroxysmal AF
- Long standing Persistent AF, defined as AF continuously present for longer
than 1 year.
- Body mass index >35kg/m2

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is freedom of AF, defined as absence of any<br /><br>atrial tachyarrhythmia without the use of antiarrhythmic drugs during 12 months<br /><br>after a single procedure, at the moment that 72 patients have had a recurrence<br /><br>of atrial tachyarrhythmia. Freedom of atrial tachyarrhythmia is defined as the<br /><br>absence of documentation of episodes of atrial tachyarrhythmia lasting more<br /><br>than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded<br /><br>outside the scope of the study. A 3-month blanking period during which<br /><br>recurrent atrial tachycardia*s are not considered a failure of the procedure,<br /><br>will be instituted conforming to current guidelines and consensus.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints include:<br /><br>- Freedom of arrhythmia after 12 months without AAD after a single procedure<br /><br>- Freedom of arrhythmia after 12 months with AAD after a single procedure<br /><br>- Freedom of arrhythmia after 12 months without AAD after both procedures<br /><br>- Freedom of arrhythmia after 5 years<br /><br>- Cost-effectiveness of both procedures in isolation, and the combination of<br /><br>both procedures<br /><br>- Quality of life </p><br>