Pulmonary Vein Ablation using Irreversible Electroporation - a safety study

Completed

Conditions: Atrial fibrillation
10007521

Registration Number: NL-OMON47967

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Patients age is * 18 years and * 80 years
* Patients must provide written, informed consent
* Patients with paroxysmal or persistent atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days.
* Patients undergoing a first-time ablation procedure for atrial fibrillation
* All pulmonary vein diameters at computed tomography or magnetic resonance imaging *26 mm
* AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device

Exclusion Criteria

* Not capable of giving informed consent
* Patients with longstanding persistent AF, defined as sustained episode lasting >1 year
* Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the LA (under conscious sedation), such as pregnancy or presence of a LA thrombus
* Patients that cannot undergo a contrast enhanced MRI-scan (e.g. implanted devices, renal function or anxiety)
* Patients that cannot undergo an esophagoscopy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Acute efficacy: Acute pulmonary vein isolation with entrance and exit block<br /><br>* Brain MRI: The occurrence of lesions on the DWI/FLAIR MRI will be scored as<br /><br>yes/no and the number of lesions will be stored.<br /><br>* Esophagoscopy: The occurrence of procedure related lesions, classified as: no<br /><br>lesion, minimal lesion (small erythema/erosion with intact mucosa), severe<br /><br>erythema/erosion and perforation<br /><br>* Pulmonary vein diameter: The occurrence of pulmonary vein stenosis (> 50 %<br /><br>reduction in diameter) as measured using the pre-CT-scan and post<br /><br>contrast-enhanced MRI.<br /><br>* Safety of investigational devices: Descriptive statistics will be used, for<br /><br>example counts, means or medians. as appropriate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Procedure duration<br /><br>* Fluoroscopy time<br /><br>* Acute procedure related complications<br /><br>* Feasibility and accuracy using MEIS during IRE ablation<br /><br>* Cardiac enzymes levels related to IRE-ablation<br /><br>* Cardiac function as determined using echocardiography</p><br>