Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation versus Repeated Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

The patient is must be a candidate for an interventional treatment strategy and
is:
* Known with a history of symptomatic persistent AF (continuous AF lasting > 7
days) or longstanding persistent AF (continuous AF lasting > 1 year),
* Refractory to or intolerant of at least one antiarrhythmic drug class I or
III,
* At least 18 years of age,
* Mentally able and willing to give informed consent.

Exclusion Criteria

* Referred specifically for a hybrid ablation,
* Previous ablation procedure,
* Longstanding persistent AF > 3 years,
* Paroxysmal atrial fibrillation,
* AF secondary to electrolyte imbalance, thyroid disease, or other reversible
or non-cardiovascular cause,
* Presence of left atrial appendage (LAA) thrombus,
* Left atrial size * 60mm (PLAX-view on TEE),
* Left ventricular ejection fraction < 40%,
* In need for other cardiac surgery then AF treatment within 12 months,
* Intolerance to heparin and warfarin,
* Unable to undergo TEE,
* Sick-sinus-syndrome
* Mitral valve insufficiency > Iº
* Carotid stenosis > 80%,
* Active infection or sepsis,
* Pleural adhesions,
* Elevated hemi diaphragm
* Significant pulmonary dysfunction as assessed by preoperative lung testing,
* Chronic obstructive pulmonary disease with a FEV1 or VC < 50% predicted,
* History of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
* History of blood clotting abnormalities,
* History of thoracic radiation,
* History of pericarditis,
* History of cardiac tamponade,
* History of thoracotomy or cardiac surgery,
* Body-mass-index > 40,
* Pregnancy,
* Life expectancy less than 12 months,
* Participation in any other clinical study involving an investigational drug
or device.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary effectiveness endpoint:<br /><br>* Freedom from any atrial tachyarrhythmia (AT) off antiarrhytmic drugs class I<br /><br>or III lasting > 5 minutes after the blanking period, evaluated by any ECG<br /><br>tracing and 7-day holter ECG at 12 months.<br /><br><br /><br>Primary safety endpoint:<br /><br>* Major complications during follow-up (e.g., transient ischemic attack,<br /><br>cerebrovascular accident, bleeding with need for PRBC, cardiac tamponade,<br /><br>pulmonary vein stenosis, myocardial infarction, phrenic nerve or vagal nerve<br /><br>injury, esophageal injury and death).</p><br>

Secondary Outcome Measures