Pulmonary Vein Isolation with Irreversible Electroporation, a pilot study

Completed

Conditions: Atrial fibrillation
10007521

Registration Number: NL-OMON47849

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Patients age is * 18 years and * 80 years
- Patients must provide written, informed consent
- Patients with paroxysmal or persistent drug-refractory, symptomatic 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 * 23 mm
- AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device
- Patients have non-valvular AF

Exclusion Criteria

- Not capable of giving informed consent
- Prior PVAI with RF or Cryo ablation
- Patients with longstanding persistent AF (defined as sustained episode lasting >1 year)
- One or more PVs with a diameter at computed tomography or magnetic resonance imaging > 23 mm
- Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the LA, such as pregnancy or presence of a LA thrombus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess:<br /><br><br /><br>- Acute pulmonary vein isolation with entrance and exit block<br /><br>- Acute device related complications </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess:<br /><br>- Maneuverability of IRE catheter in the left atrium<br /><br>- Positioning of catheter at PV antrum<br /><br>- Acute procedural complications<br /><br>- Procedural duration<br /><br>- Fluoroscopy time<br /><br>- Feasibility of MEIS contact measurements</p><br>