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

NCT06801392 | Recruiting

• 1 other identifier: Varipulse_efficacy_and_safety
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; pulsed-field ablation; varipulse

Outcome Measures

Primary Outcomes (10)

• 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.

  during the procedure

• 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.

  during the procedure

• Serum Creatinine Concentration

  Serum creatinine concentration

  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.

• Serum Cystatin C Concentration

  Serum cystatin C concentration.

  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.

• Serum Neutrophil Gelatinase-Associated Lipocalin Concentration

  Serum neutrophil gelatinase-associated lipocalin (NGAL).

  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.

• Red Blood Cell Microparticles

  The concentration of red blood cell microparticles (using flow cytometry).

  Blood samples will be taken (1) at the beginning of the procedure from the femoral vein, (2) at the end of all ablations before sheath removal, and (3) in the morning on the day after the procedure.

• Lactate Dehydrogenase

  Serum lactate dehydrogenase will be determined.

  Blood samples will be taken (1) at the beginning of the procedure from the femoral vein, (2) at the end of all ablations before sheath removal, and (3) in the morning on the day after the procedure.

• Platelet Activation Markers

  The platelet activation markers (CD62P, CD42b and PAC-1) will be determined

  Blood samples will be taken (1) at the beginning of the procedure from the femoral vein, (2) at the end of all ablations before sheath removal, and (3) in the morning on the day after the procedure.

• Prothrombosis Fragments

  Prothrombin fragments will be determined

  Blood samples will be taken (1) at the beginning of the procedure from the femoral vein, (2) at the end of all ablations before sheath removal, and (3) in the morning on the day after the procedure.

• Platelet-Thrombotic Microparticles

  Platelet-thrombotic microparticles will be determined

  Blood samples will be taken (1) at the beginning of the procedure from the femoral vein, (2) at the end of all ablations before sheath removal, and (3) in the morning on the day after the procedure.

Other Outcomes (1)

• Procedure complications assessment

  0 - 30 days after the procedure

Study Arms (4)

Ablation strategy 1

PVI + three pairs of overlapping lesions on the posterior wall, mitral isthmus ablation optional

Procedure: pulsed-field ablation

Ablation strategy 2

PVI + three single lesions on the posterior wall, mitral isthmus ablation optional

Procedure: pulsed-field ablation

Ablation strategy 3

PVI + four single lesions on the posterior wall, mitral isthmus ablation optional

Procedure: pulsed-field ablation

Ablation strategy 4

PVI + four pairs of overlapping lesions on the posterior wall, mitral isthmus ablation optional

Procedure: pulsed-field ablation

Interventions

pulsed-field ablation PROCEDURE

PVI + PW ablation

Ablation strategy 1; Ablation strategy 2; Ablation strategy 3; Ablation strategy 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF ablation indication

You may qualify if:

• non-paroxysmal atrial fibrillation
• an indication for catheter ablation according current guidelines
• willingness to sign informed content.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pavel Osmancik, MD, PhD

CONTACT

+420267 161 111; pavel.osmancik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 30, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-01

Locations

CZ (1)