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Pulmonary Vein Isolation with Irreversible Electroporation, a pilot study

Pulmonary Vein Isolation with Irreversible Electroporation, a pilot study - PVI using IRE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47849
Enrollment
10
Registered
2017-08-29
Start date
2018-11-12
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Atrial fibrillation

Interventions

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

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 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

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

Design outcomes

Primary

MeasureTime frame
To assess: - Acute pulmonary vein isolation with entrance and exit block - Acute device related complications

Secondary

MeasureTime frame
To assess: - Maneuverability of IRE catheter in the left atrium - Positioning of catheter at PV antrum - Acute procedural complications - Procedural duration - Fluoroscopy time - Feasibility of MEIS contact measurements

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)