Hemolysis, Red blood cell breakdown, Erythrocyte destruction, Red blood cell destruction Breakdown of red blood cells
Conditions
Interventions
None listed
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is aged 18 to 85 years Subject has been diagnosed with symptomatic paroxysmal or non-paroxysmal AF Scheduled for a primary PVI procedure using the PulseSelect™, FARAPULSE™, Volt™ or Sphere-360™ PFA system.
Exclusion criteria
Exclusion criteria: As this is an exploratory study in an area where limited prior data exist, we chose not to apply any exclusion criteria. This allows us to capture a complete and representative spectrum of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the degree of hemolysis after PFA with PulseSelect™, Farapulse™, Volt™ and Sphere-360™ systems, assessed by specific hemolysis blood markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the relationship between the number of PFA applications and hemolysis, correlation between hemolysis and renal function, diagnostic value of urine dipstick testing for hemoglobinuria in identifying patients at risk of hemolysis after PFA and correlation between PFA and myocardial injury. | — |
Countries
Netherlands
Contacts
Public ContactR.E. Bolhuis
St. Antonius Ziekenhuis
Outcome results
None listed