Atrial FibrillationNCT06096428
Hemolysis During Pulsed-field and Radiofrequency Ablation
An observational study of Atrial Fibrillation and Hemolysis, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Hemolysis during and after catheter ablation will be compared between catheter ablation performed using radiofrequency and pulsed-field energy. Consecutive patients indicated for catheter ablation for AF will be enrolled, catheter ablation will be done using standard catheters (Qdot, Biosense Webster for RF, and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Hemolysis, Pulsed-field Ablation
- What is being tested?
- Pulsed-field ablation and Radiofrequency ablation
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Nov 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with symptomatic paroxysmal or non-paroxysmal atrial fibrillation indicated according current guideliens for the cathter ablation of atrial fibrillation, i.e. pulmonary vein isolation
Who may be able to join
- symptomatic atrial fibrillation indicated for catheter ablation
- willingness to participate
Who cannot join
- pregnancy
- any known malignant or non-malignant hematological disorder
- malignancy
- age > 75 years
- any disease associated with hemolysis
- hemoglobin concentration less than 100 g/L
- liver cirrhosis
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
About this study
Official title: The Assessment of Intravascular Peri-procedural Hemolysis During Catheter Ablation for Atrial Fibrillation Using Radiofrequency and Pulsed-field Energy
Hemolysis during and after catheter ablation will be compared between catheter ablation performed using radiofrequency and pulsed-field energy. Consecutive patients indicated for catheter ablation for AF will be enrolled, catheter ablation will be done using standard catheters (Qdot, Biosense Webster for RF, and Farapulse, Boston-Scientific for PF). Blood samples will be drawn at the beginning of ablation (T1), at the end of ablation (T2), and one day after the procedure (T3). Hemolysis will be analyzed using flow cytometry, ELISA and standard biochemistry and compared between RF and PF patients, Primary hypothesis is that hemolysis level will be higher after PF ablation compared to RF ablation.
Read the detailed description
Catheter ablation presents the most effective treatment for atrial fibrillation (AF). It consists of the electrical isolation of the pulmonary veins. Several kinds of ablation energies can be used for the ablation. So far, the most often kind of energy was radiofrequency (RF) energy that leads to thermal destruction of the cardiac tissue. Newly, pulsed-field (PF) energy was developed for catheter ablation of AF. The use of PF energy consists in ultra-short, high-power application of electrical impulses that lead to fast, non-thermal cardiac tissue destruction.
Despite significant advantages, such as tissue selectivity, short procedure duration, and high durability of ablated lesions, the use of PF energy could also have other adverse effects. Recently, renal failure due to accelerated peri-procedural hemolysis in patients with pre-existed renal disease was described after PF ablation for AF.
The aim of the project is to assess and compare the level of hemolysis during catheter ablation for AF using PF and RF energy. Sixty consecutive patients indicated for catheter ablation for AF according to the standard recommendation (symptomatic paroxysmal or non-paroxysmal AF) will be enrolled. Consecutive patients as they are scheduler for procedure will be enrolled without randomization. In 40 patients (20 paroxysmal and 20 non-paroxysmal), the ablation will be done using PF energy, and in 20 patients using RF energy.
In all patients, intracardiac echocardiography (Accunav, Siemens, Germany) and fluoroscopy will be used for navigation. The procedures will be done as it is currently routinely done in the EP lab. In RF patients, 4 vascular access will be used (one for 10-pole catheter placed into the coronary sinus, one for intracardiac echocardiography probe, and 2 for transseptal sheaths). Two transseptal punctures will be done under the guidance of intracardiac echocardiography using SL1 sheaths (Abbott, USA). One transseptal access will be used for diagnostic circular mapping catheter (Lasso, Biosense-Webster, USA), the other for the ablation catheter. The RF ablation will be performed using SmartTouch or QDot ablation catheters (both Biosense-Webster, USA); however, ablation will be driven by the ablation index even if QDot catheter is used. The RF ablation will be performed using ablation index (400-450 on anterior-superior aspects and 350-400 on posterior aspects of PVs), the QDot Plus (high-power short-duration) regimen won´t be used. The goal will be to achieve the entrance and exit block of all 4 PVs. In non-paroxysmal patients, additional ablations could be done at the discretion of the treating physician (fractionated singnals, lines).
In the PF patients, two vascular access will be obtained. The first will be used for intracardiac echocardiography, the second for the transseptal sheath. Transseptal puncture will be done also using SL1 sheath (Abbott, USA), and using over-the-wire technique, this sheath will be exchanged by the 16-F Faradrive sheath (BSCI, USA). The ablation then will be done using pentaspline ablation catheter (Farawave, Boston Scientific). Four application of pulsed-field energy in basket configuration, and 4 application in flower configuration will be applied to each pulmonary vein. Additional pulsed-field energy application could be added if the signal in PV are present. In non-paroxysmal patients, additional pulsed-field energy application could be applied on the discretion of the operator on the posterior wall, or mitral isthmus.
Blood samples will be taken at the beginning of the procedure from the femoral vein (T1), at the end of the procedure after ablation lesions completion (T2), and one day after the procedure (T3). Hemolysis will be assessed in all three samples 1) using flow cytometry (by means of measurement of "erythrocyte microparticles detected by the presence of antigens glycophorin A and Annexin V) and 2) using ELISA method (assessment of "cell free hemoglobin " concentration). Additionelly, standard biochemistry and blood count analysis will be done from the T1 and T3 samples (the concentration of lactate dehydrogenase, haptoglobin, indirect bilirubin, reticulocytes, and immature reticulocyte fraction).
Primary hypothesis is that the level of hemolysis will be higher after PF ablation compared to RF ablation. Since no studies were published on the hemolysis either during RF or PF ablation, no reliable power calculation can be done.
- Conditions
- Atrial Fibrillation, Hemolysis, Pulsed-field Ablation
- Being tested
- Pulsed-field ablation, Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed-field ablationDevice
Pulsed-field ablation will be done using pentaspline catheter (Farawave, Boston Scientific) and pulsed-field energy generator. The goal will be achieve of electrical isolation of pulmonary veins.
Radiofrequency ablationDevice
Pulmonary vein isolation will be done using radiofrequency catheter (Qdot, Biosense-Webster) and generator of radiofrequency energy (nGEN, Biosense-Webster).
| Study group | Role | What they receive |
|---|---|---|
| Pulsed-field group | Patients will undergo catheter ablation for atrial fibrillation using pulsed-field energy Receives: Device: Pulsed-field ablation | |
| Radiofrequency group | Patients will undergo catheter ablation using radiofrequency energx Receives: Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte (red blood cells, RBC) microparticles
The concentration of erythrocyte microparticles /µL. Analysis using flow cytometry, as the concentration of total erythrocyte mictoparticles in platelet-rich plasma.
Measured: One day after the procedure
Cell free hemoglobin
The concentration of cell-free hemoglobin, using ELISA measurement, in g/L
Measured: One day after the procedure
Secondary outcomes (5)
Lactate-dehydrogenase
The concentration of lactate-dehydrogenase (µkat/L)
Measured: One day after the procedure
Haptoglobin
The concentration of haptoglobin (g/L)
Measured: One day after the procedure
Indirect bilirubin
The concentration of indirect bilirubin (µmol/L)
Measured: One day after the procedure
Reticulocytes
The absolute concentration of reticulocytes
Measured: One day after the procedure
Immature reticulocyte fraction (IRF)
The percentage of immature reticulocytes of all reticulocytes (%)
Measured: One day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Nov 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096428
- Sponsor's protocol ID
- PFA HEMOLYSIS
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared based on individual request
Publications
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.
PubMed 23273528Reddy 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.
PubMed 33933412Ekanem 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.
PubMed 35647644Liu D, Li Y, Zhao Q. Effects of Inflammatory Cell Death Caused by Catheter Ablation on Atrial Fibrillation. J Inflamm Res. 2023 Aug 17;16:3491-3508. doi: 10.2147/JIR.S422002. eCollection 2023.
PubMed 37608882Osmancik P, Bacova B, Herman D, Hozman M, Fiserova I, Hassouna S, Melenovsky V, Karch J, Vesela J, Benesova K, Reddy VY. Periprocedural Intravascular Hemolysis During Atrial Fibrillation Ablation: A Comparison of Pulsed Field With Radiofrequency Ablation. JACC Clin Electrophysiol. 2024 Jul;10(7 Pt 2):1660-1671. doi: 10.1016/j.jacep.2024.05.001. Epub 2024 May 16.
PubMed 38852101
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Intravascular Peri-procedural Hemolysis During Catheter Ablation for Atrial Fibrillation Using Radiofrequency and Pulsed-field Energy
- ClinicalTrials.gov ID
- NCT06096428
- Acronym / sponsor ID
- PFA HEMOLYSIS
- Conditions
- Atrial Fibrillation, Hemolysis, Pulsed-field Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemolysis during and after catheter ablation will be compared between catheter ablation performed using radiofrequency and pulsed-field energy. Consecutive patients indicated for catheter ablation for AF will be enrolled, catheter ablation will be done using standard catheters (Qdot, Biosense Webster for RF, and Farapulse, Boston-Scientific for PF). Blood samples will be drawn at the beginning of ablation (T1), at the end of ablation (T2), and one day after the procedure (T3). Hemolysis will be analyzed using flow cytometry, ELISA and standard biochemistry and compared between RF and PF patients, Primary hypothesis is that hemolysis level will be higher after PF ablation compared to RF ablation.
Detailed description
Catheter ablation presents the most effective treatment for atrial fibrillation (AF). It consists of the electrical isolation of the pulmonary veins. Several kinds of ablation energies can be used for the ablation. So far, the most often kind of energy was radiofrequency (RF) energy that leads to thermal destruction of the cardiac tissue. Newly, pulsed-field (PF) energy was developed for catheter ablation of AF. The use of PF energy consists in ultra-short, high-power application of electrical impulses that lead to fast, non-thermal cardiac tissue destruction.
Despite significant advantages, such as tissue selectivity, short procedure duration, and high durability of ablated lesions, the use of PF energy could also have other adverse effects. Recently, renal failure due to accelerated peri-procedural hemolysis in patients with pre-existed renal disease was described after PF ablation for AF.
The aim of the project is to assess and compare the level of hemolysis during catheter ablation for AF using PF and RF energy. Sixty consecutive patients indicated for catheter ablation for AF according to the standard recommendation (symptomatic paroxysmal or non-paroxysmal AF) will be enrolled. Consecutive patients as they are scheduler for procedure will be enrolled without randomization. In 40 patients (20 paroxysmal and 20 non-paroxysmal), the ablation will be done using PF energy, and in 20 patients using RF energy.
In all patients, intracardiac echocardiography (Accunav, Siemens, Germany) and fluoroscopy will be used for navigation. The procedures will be done as it is currently routinely done in the EP lab. In RF patients, 4 vascular access will be used (one for 10-pole catheter placed into the coronary sinus, one for intracardiac echocardiography probe, and 2 for transseptal sheaths). Two transseptal punctures will be done under the guidance of intracardiac echocardiography using SL1 sheaths (Abbott, USA). One transseptal access will be used for diagnostic circular mapping catheter (Lasso, Biosense-Webster, USA), the other for the ablation catheter. The RF ablation will be performed using SmartTouch or QDot ablation catheters (both Biosense-Webster, USA); however, ablation will be driven by the ablation index even if QDot catheter is used. The RF ablation will be performed using ablation index (400-450 on anterior-superior aspects and 350-400 on posterior aspects of PVs), the QDot Plus (high-power short-duration) regimen won´t be used. The goal will be to achieve the entrance and exit block of all 4 PVs. In non-paroxysmal patients, additional ablations could be done at the discretion of the treating physician (fractionated singnals, lines).
In the PF patients, two vascular access will be obtained. The first will be used for intracardiac echocardiography, the second for the transseptal sheath. Transseptal puncture will be done also using SL1 sheath (Abbott, USA), and using over-the-wire technique, this sheath will be exchanged by the 16-F Faradrive sheath (BSCI, USA). The ablation then will be done using pentaspline ablation catheter (Farawave, Boston Scientific). Four application of pulsed-field energy in basket configuration, and 4 application in flower configuration will be applied to each pulmonary vein. Additional pulsed-field energy application could be added if the signal in PV are present. In non-paroxysmal patients, additional pulsed-field energy application could be applied on the discretion of the operator on the posterior wall, or mitral isthmus.
Blood samples will be taken at the beginning of the procedure from the femoral vein (T1), at the end of the procedure after ablation lesions completion (T2), and one day after the procedure (T3). Hemolysis will be assessed in all three samples 1) using flow cytometry (by means of measurement of "erythrocyte microparticles detected by the presence of antigens glycophorin A and Annexin V) and 2) using ELISA method (assessment of "cell free hemoglobin " concentration). Additionelly, standard biochemistry and blood count analysis will be done from the T1 and T3 samples (the concentration of lactate dehydrogenase, haptoglobin, indirect bilirubin, reticulocytes, and immature reticulocyte fraction).
Primary hypothesis is that the level of hemolysis will be higher after PF ablation compared to RF ablation. Since no studies were published on the hemolysis either during RF or PF ablation, no reliable power calculation can be done.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed-field group | – | Device: Pulsed-field ablationPatients will undergo catheter ablation for atrial fibrillation using pulsed-field energy |
| Radiofrequency group | – | Device: Radiofrequency ablationPatients will undergo catheter ablation using radiofrequency energx |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic paroxysmal or non-paroxysmal atrial fibrillation indicated according current guideliens for the cathter ablation of atrial fibrillation, i.e. pulmonary vein isolation
Key inclusion criteria (2 listed)
- symptomatic atrial fibrillation indicated for catheter ablation
- willingness to participate
Key exclusion criteria (7 listed)
- pregnancy
- any known malignant or non-malignant hematological disorder
- malignancy
- age > 75 years
- any disease associated with hemolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed-field ablationPulsed-field ablation will be done using pentaspline catheter (Farawave, Boston Scientific) and pulsed-field energy generator. The goal will be achieve of electrical isolation of pulmonary veins. | Device | Pulsed-field group |
| Radiofrequency ablationPulmonary vein isolation will be done using radiofrequency catheter (Qdot, Biosense-Webster) and generator of radiofrequency energy (nGEN, Biosense-Webster). | Device | Radiofrequency group |
Primary outcome
Erythrocyte (red blood cells, RBC) microparticles
Time frame: One day after the procedure
The concentration of erythrocyte microparticles /µL. Analysis using flow cytometry, as the concentration of total erythrocyte mictoparticles in platelet-rich plasma.
Cell free hemoglobin
Time frame: One day after the procedure
The concentration of cell-free hemoglobin, using ELISA measurement, in g/L
5 secondary outcomes
Lactate-dehydrogenase
Time frame: One day after the procedure
Haptoglobin
Time frame: One day after the procedure
Indirect bilirubin
Time frame: One day after the procedure
Reticulocytes
Time frame: One day after the procedure
Immature reticulocyte fraction (IRF)
Time frame: One day after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Results publication: PubMed 23273528Zoni-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.
- Results publication: PubMed 33933412Reddy 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.
- Results publication: PubMed 35647644Ekanem 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.
- Results publication: PubMed 37608882Liu D, Li Y, Zhao Q. Effects of Inflammatory Cell Death Caused by Catheter Ablation on Atrial Fibrillation. J Inflamm Res. 2023 Aug 17;16:3491-3508. doi: 10.2147/JIR.S422002. eCollection 2023.
- Derived from this study: PubMed 38852101Osmancik P, Bacova B, Herman D, Hozman M, Fiserova I, Hassouna S, Melenovsky V, Karch J, Vesela J, Benesova K, Reddy VY. Periprocedural Intravascular Hemolysis During Atrial Fibrillation Ablation: A Comparison of Pulsed Field With Radiofrequency Ablation. JACC Clin Electrophysiol. 2024 Jul;10(7 Pt 2):1660-1671. doi: 10.1016/j.jacep.2024.05.001. Epub 2024 May 16.
- Individual participant dataSharing planned: Yes. Data will be shared based on individual request
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Hemolysis, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte (red blood cells, RBC) microparticles (time frame: One day after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096428, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.