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Left Atrial Posterior Wall and Mitral Isthmus PF Ablation in Non-Paroxysmal AF Patients

ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharles University, Czech Republic

About this trial

An observational study evaluating efficacy and safety of the Varipulse catheter in pulsed-field ablation of atrial fibrillation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

non-paroxysmal atrial fibrillation

an indication for catheter ablation according current guidelines

willingness to sign informed content.

Disqualifiers

hematological disorders that can be associated with spontaneous hemolysis

chronic kidney disease stage 3 or worse

previous left atrial ablation (either using pulsed-field or radiofrequency energy)

Trial population

Patients with AF ablation indication

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • pulsed-field ablation

    Procedure/Surgery

    PVI + PW ablation

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: Ablation strategy 11 intervention
Group B: Ablation strategy 21 intervention
Group C: Ablation strategy 31 intervention
Group D: Ablation strategy 41 intervention

Trial outcomes

Primary outcomes

1

Acute Success of the Left Atrial Posterior Wall Ablation

After the last application of PE energy, and after a 20-minute wait, all lesions will be verified by careful 3D-electro-anatomical mapping (voltage and activation mapping) and by conventional pacing manoeuvres.

Time frame
during the procedure
2

Acute Success of the Mitral Isthmus Ablation

After the last application of PE energy, and after a 20-minute wait, all lesions will be verified by careful 3D-electro-anatomical mapping (voltage and activation mapping) and by conventional pacing manoeuvres.

Time frame
during the procedure
3

Serum Creatinine Concentration

Serum creatinine concentration

Time frame
Blood samples will be taken (1) at the beginning of the procedure from the femoral vein and (2) in the morning on the day after the procedure.
4

Serum Cystatin C Concentration

Serum cystatin C concentration.

Time frame
Blood samples will be taken (1) at the beginning of the procedure from the femoral vein and (2) in the morning on the day after the procedure.

Secondary outcomes

Other outcomes

1

Procedure complications assessment

Time frame
0 - 30 days after the procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Biosense Webster, Inc.

Collaborator

Source ClinicalTrials.gov
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