Renal Function and Hemolysis After Pulsed-field Ablation for Atrial Fibrillation

NCT06198933 | Unknown

• 1 other identifier: PFA RENAL HEMOLYSIS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to assess hemolysis and renal function after catheter ablation for atrial fibrillation using pulsed-field energy. Hemolysis will be determined using the concentration of red blood cell microparticles at the end of the ablation (when all ablation were done, before sheath removal). Hemoglobinuria will be assessed one day after the procedure. Renal functions will be assessed one and three day after the procedure using standard parameters (creatinine, urea). The goal is to assess the acute worsening fo renal functions after pulsed-field ablation in relation to the number of PF applications, and to the degree of immediate post-procedural hemolysis.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pulsed-fied ablation; hemolysis; renal function

Outcome Measures

Primary Outcomes (3)

• Red blood cell microparticles

  The concentration of red blood cell microparticles in the plasma assessed using flow cytometry

  day of the procedure - at the end of the procedure

• Hemoglobinuria

  The concentration of hemoglobin in urine

  One day after the procedure

• Creatinine three days

  The concentration of creatinine three days after ablation

  3 days after the procedure

Secondary Outcomes (3)

• Lactate dehydrogenase

  the day of the procedure - at the end of the procedure

• Haptoglobin

  the day of the procedure - at the end of the procedure

• Creatinine one day

  one day after the procedure

Study Arms (1)

Pulsed-field ablation group

Patient with atrial fibrillation will undergo catheter ablation using pulsed-field energy

Device: Pulsed-field ablation

Interventions

Pulsed-field ablation DEVICE

Patients will atrial fibrillation will undergo catheter ablation using pulsed-field energy

Pulsed-field ablation group

Eligibility Criteria

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

Study Population

Patient will symptomatic paroxysmal or non-paroxysmal atrial fibrillation indicated for catheter ablation according to the standard criteria will be enrolled.

You may qualify if:

• symptomatic paroxysmal or non-paroxysmal atrial fibrillation

You may not qualify if:

• known hematologic disorders
• disorders associated with increased hemolysis
• known significant hepatic disease
• patient in permanent hemodialysis

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

RECRUITING

Related Publications (4)

• Zoni-Berisso M, Filippi A, Landolina M, Brignoli O, D'Ambrosio G, Maglia G, Grimaldi M, Ermini G. Frequency, patient characteristics, treatment strategies, and resource usage of atrial fibrillation (from the Italian Survey of Atrial Fibrillation Management [ISAF] study). Am J Cardiol. 2013 Mar 1;111(5):705-11. doi: 10.1016/j.amjcard.2012.11.026. Epub 2012 Dec 28.

  PMID: 23273528 BACKGROUND

• Wolf PA, Benjamin EJ, Belanger AJ, Kannel WB, Levy D, D'Agostino RB. Secular trends in the prevalence of atrial fibrillation: The Framingham Study. Am Heart J. 1996 Apr;131(4):790-5. doi: 10.1016/s0002-8703(96)90288-4. No abstract available.

  PMID: 8721656 BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.

  PMID: 33933412 BACKGROUND

• Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P; MANIFEST-PF Cooperative. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022 Sep 1;24(8):1256-1266. doi: 10.1093/europace/euac050.

  PMID: 35647644 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for the assessment of hemolysis and renal functions

MeSH Terms

Conditions

Atrial Fibrillation; Hemolysis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: May 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)