Catheter ablation versus video assisted thoracoscopic surgery for the treatment of (longstanding) persistent atrial fibrillatio

Withdrawn

Conditions: 10007521
Atrial fibrillation

Registration Number: NL-OMON41871

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Patients age is * 18 years
- Patients with persistent or longstanding persistent atrial fibrillation.
- Patients undergoing a first time invasive treatment procedure for persistent atrial fibrillation
- AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device.
- Patients must give informed consent to participate

Exclusion Criteria

- Patients suffering from paroxysmal atrial fibrillation
- Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the left atrium, such as pregnancy or presence of a left atrial thrombus
- Patients with any contra-indications for VATS such as pleural adhesions, elevated hemidiaphragm or prior lung/cardiac surgery
- Active infection or sepsis
- Body mass index> 40
- mitral or aortic valve regurgitation above grade 2
- moderate to severe mitral or aortic stenosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Success after 1 procedure with a follow-up duration of 12 months.<br /><br>Success is defined as: freedom of atrial fibrillation/atrial flutter/atrial<br /><br>tachycardia >30 seconds following the 3 months blanking period in the absence<br /><br>of Class I and III AAD therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-The incidence of periprocedural complications.<br /><br>-Clinical success (75% or greater reduction in the number of AF episodes, the<br /><br>duration of AF episodes, or the % time a patient is in AF in the presence or<br /><br>absence of previously ineffective AAD therapy) after the first procedure.<br /><br>-Procedural duration.<br /><br>-Success and clinical success after 2 procedures with a follow-up duration of<br /><br>12 months. A second procedure will be performed through catheter ablation in<br /><br>both groups.<br /><br>-Quality of life measurements before and 6 months after the first procedure.</p><br>