Pulmonary Vein Ablation using Irreversible Electroporation - a safety study

Pulmonary Vein Ablation using Irreversible Electroporation - a safety study - Safety of PVI using IRE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47967

Enrollment

Registered

2019-04-17

Start date

2019-05-10

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Pulmonary vein antrum isolation with irreversible electroporation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
* Procedure duration * Fluoroscopy time * Acute procedure related complications * Feasibility and accuracy using MEIS during IRE ablation * Cardiac enzymes levels related to IRE-ablation * Cardiac function as determined using echocardiography	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)