Atrial FibrillationNCT05603637
The Effect of Pulsed-field and Radiofrequency Ablation on Platelet, Coagulation and Inflammation
A study testing Catheter ablation using SmartTouch radiofrequency ablation catheter and Catheter ablation using Farawave pulsed-field ablation catheter in people with Atrial Fibrillation, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The aim of the study is to compare platelet activation, activation of the coagulation and inflammation cascade during catheter ablation for atrial fibrillation using radiofrequency or pulsed-field energy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation using SmartTouch radiofrequency ablation catheter and Catheter ablation using Farawave pulsed-field ablation catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2022to 1 Feb 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial fibrillation - paroxysmal of persistent
Who cannot join
- pregnancy
- left atrium > 60 mm
- mechanical valve
- known prothrombotic state
- rheumatic heart disease
- severe valve disease (i.e. mitral insufficiency > 2, aortic stenosis)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
Pavel Osmancik, MD, PhD, 00420 ext. 721544447, pavel.osmancik@volny.cz
About this study
Official title: The Effect of Pulsed-field and Radiofrequency Ablation for Atrial Fibrillation on Platelet Activity, Coagulation and Inflammation
The aim of the study is to compare platelet activation, activation of the coagulation and inflammation cascade during catheter ablation for atrial fibrillation using radiofrequency or pulsed-field energy. Patients with atrial fibrillation and standard indication for ablation according to the current guidelines will be randomized to ablation either using radiofrequency of pulsed-field energy. The endpoints will be parameters of platelet activation, activation of coagulation, and changes in inflammatory markers during ablation.
Read the detailed description
Catheter ablation for atrial fibrillation (AF) , i.e. pulmonary vein isolation, is associated with the activation of platelets, coagulation cascade and inflammatory parameters. Thrombus in the left atrium could arise on sheaths or wires, but the highest risk presents the ablations itself. Radiofrequency ablation leads to immediate endocardial damage that presents strong pro-thrombotic milieu. To avoid thrombus formation on catheters in the left atrium, heparin with target activated clotting time (ACT) of 250-300 is given during the procedure.
Newly, pulsed - field ablation has been widely emerged. Since the pulsed-field energy presents substantially different kind of ablation energy, and the mechanism of action differs substantially (no thermal injury, no acute necrosis), also the effect on platelets, coagulation and inflammatory parameters could differ substantially.
The investigators therefore initiate a study comparing the effect of radiofrequency and pulsed-field ablation on parameters of platelet activation, coagulation and inflammation during catheter ablation.
Patients with AF indicated for catheter ablation according current guidelines will be randomized to radiofrequency or pulsed-field ablation. The procedure will be done using standard approach from one or both femoral veins under moderate analgesia. Using intracardiac echocardiography, and by means of SL1 sheath (Abbott, USA), transseptal puncture will be done. In patients in the radiofrequency arm, Lasso (circular mapping catheter) will be inserted in all four pulmonary veins, and using Smart Touch ablation catheter (Biosense Webster, USA), pulmonary vein isolation will be done with target ablation index of 400 on anterior and superior aspects of pulmonary veins and 350 of the posterior wall of the left atrium. In patients in the pulsed-field arm, SL1 sheath will be replaced by Faradrive sheath (Boston Scientific, USA), and pulmonary vein isolation will be done using Farawave catheter (Boston Scientific, USA).
Blood samples will be drawn at the beginning of the procedure from the right atrium (S1), after the transeptal puncture before the ablation from the left atrium (S2), after the ablation when all 4 pulmonary vein are isolated (S3), 24 hours after the procedure before patient discharge (S4), and 3 months after the procedure during follow-up.
Platelet activity will be determined using flow cytometry (membrane expression of P-selectin (CD62P) antigen, active part of the glycoprotein IIb/IIIa (PAC-1), CD 41/61 antigens). Changes in coagulation will be determined by measuring D-dimers and fibrin-monomers. Regarding the inflammatory parameters, plasma concentration of interleukin-6, and membrane activation antigens on leukocytes will be assessed using flow cytometry.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation using SmartTouch radiofrequency ablation catheter, Catheter ablation using Farawave pulsed-field ablation catheter
- Keywords
- atrial fibrillation, catheter ablation, radiofrequency ablation, pulsed-field ablation, platelet activity, coagulation
- Medical subject headings
- Atrial Fibrillation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation using SmartTouch radiofrequency ablation catheterProcedure or surgery
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using radiofrequency energy with SmatTouch ablation catheter (Biosense Webster, USA)
Catheter ablation using Farawave pulsed-field ablation catheterProcedure or surgery
Patients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using pulsed-field energy with Farawave ablation catheter (Boston Scientific, USA)
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation arm | Active comparator | Patients will undergo pulmonary vein isolation by means of radiofrequency energy. The ablation will be done using SmartTouch ablation catheter (Biosense Webster, USA). Receives: Procedure: Catheter ablation using SmartTouch radiofrequency ablation catheter |
| Pulsed- field ablation arm | Experimental | Patients will undergo pulmonary vein isolation by means of pulsed-field ablation. The ablation will be done using Farawave ablation catheter (Boston Scientific, USA). Receives: Procedure: Catheter ablation using Farawave pulsed-field ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Membrane expression of CD62P
Platelet activity determined by activation marker
Measured: 3 months
Membrane expression of PAC-1
Platelet activity determined by activation marker
Measured: 3 months
Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor
Changes in the coagulation cascade
Measured: 3 months
Concentration in interleukin-6 and membrane expression of leukocyte activation markers
CHanges in parameters of inflammation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Osmancik, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603637
- Sponsor's protocol ID
- PFA-RFA Thrombo
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be shared on demand
Publications
Osmancik P, Bacova B, Hozman M, Pistkova J, Kunstatova V, Sochorova V, Waldauf P, Hassouna S, Karch J, Vesela J, Poviser L, Znojilova L, Filipcova V, Benesova K, Herman D. Myocardial Damage, Inflammation, Coagulation, and Platelet Activity During Catheter Ablation Using Radiofrequency and Pulsed-Field Energy. JACC Clin Electrophysiol. 2024 Mar;10(3):463-474. doi: 10.1016/j.jacep.2023.11.001. Epub 2023 Nov 6.
PubMed 38085214
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pulsed-field and Radiofrequency Ablation for Atrial Fibrillation on Platelet Activity, Coagulation and Inflammation
- ClinicalTrials.gov ID
- NCT05603637
- Acronym / sponsor ID
- PFA-RFA Thrombo
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, radiofrequency ablation, pulsed-field ablation, platelet activity, coagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 2 Nov 2022 (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.
The aim of the study is to compare platelet activation, activation of the coagulation and inflammation cascade during catheter ablation for atrial fibrillation using radiofrequency or pulsed-field energy. Patients with atrial fibrillation and standard indication for ablation according to the current guidelines will be randomized to ablation either using radiofrequency of pulsed-field energy. The endpoints will be parameters of platelet activation, activation of coagulation, and changes in inflammatory markers during ablation.
Detailed description
Catheter ablation for atrial fibrillation (AF) , i.e. pulmonary vein isolation, is associated with the activation of platelets, coagulation cascade and inflammatory parameters. Thrombus in the left atrium could arise on sheaths or wires, but the highest risk presents the ablations itself. Radiofrequency ablation leads to immediate endocardial damage that presents strong pro-thrombotic milieu. To avoid thrombus formation on catheters in the left atrium, heparin with target activated clotting time (ACT) of 250-300 is given during the procedure.
Newly, pulsed - field ablation has been widely emerged. Since the pulsed-field energy presents substantially different kind of ablation energy, and the mechanism of action differs substantially (no thermal injury, no acute necrosis), also the effect on platelets, coagulation and inflammatory parameters could differ substantially.
The investigators therefore initiate a study comparing the effect of radiofrequency and pulsed-field ablation on parameters of platelet activation, coagulation and inflammation during catheter ablation.
Patients with AF indicated for catheter ablation according current guidelines will be randomized to radiofrequency or pulsed-field ablation. The procedure will be done using standard approach from one or both femoral veins under moderate analgesia. Using intracardiac echocardiography, and by means of SL1 sheath (Abbott, USA), transseptal puncture will be done. In patients in the radiofrequency arm, Lasso (circular mapping catheter) will be inserted in all four pulmonary veins, and using Smart Touch ablation catheter (Biosense Webster, USA), pulmonary vein isolation will be done with target ablation index of 400 on anterior and superior aspects of pulmonary veins and 350 of the posterior wall of the left atrium. In patients in the pulsed-field arm, SL1 sheath will be replaced by Faradrive sheath (Boston Scientific, USA), and pulmonary vein isolation will be done using Farawave catheter (Boston Scientific, USA).
Blood samples will be drawn at the beginning of the procedure from the right atrium (S1), after the transeptal puncture before the ablation from the left atrium (S2), after the ablation when all 4 pulmonary vein are isolated (S3), 24 hours after the procedure before patient discharge (S4), and 3 months after the procedure during follow-up.
Platelet activity will be determined using flow cytometry (membrane expression of P-selectin (CD62P) antigen, active part of the glycoprotein IIb/IIIa (PAC-1), CD 41/61 antigens). Changes in coagulation will be determined by measuring D-dimers and fibrin-monomers. Regarding the inflammatory parameters, plasma concentration of interleukin-6, and membrane activation antigens on leukocytes will be assessed using flow cytometry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation arm | Active comparator | Procedure: Catheter ablation using SmartTouch radiofrequency ablation catheterPatients will undergo pulmonary vein isolation by means of radiofrequency energy. The ablation will be done using SmartTouch ablation catheter (Biosense Webster, USA). |
| Pulsed- field ablation arm | Experimental | Procedure: Catheter ablation using Farawave pulsed-field ablation catheterPatients will undergo pulmonary vein isolation by means of pulsed-field ablation. The ablation will be done using Farawave ablation catheter (Boston Scientific, USA). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- atrial fibrillation - paroxysmal of persistent
Key exclusion criteria (6 listed)
- pregnancy
- left atrium > 60 mm
- mechanical valve
- known prothrombotic state
- rheumatic heart disease
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 |
|---|---|---|
| Catheter ablation using SmartTouch radiofrequency ablation catheterPatients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using radiofrequency energy with SmatTouch ablation catheter (Biosense Webster, USA) | Procedure or surgery | Radiofrequency ablation arm |
| Catheter ablation using Farawave pulsed-field ablation catheterPatients will undergo catheter ablation for atrial fibrillation, i.e. pulmonary vein isolation, using pulsed-field energy with Farawave ablation catheter (Boston Scientific, USA) | Procedure or surgery | Pulsed- field ablation arm |
Primary outcome
Membrane expression of CD62P
Time frame: 3 months
Platelet activity determined by activation marker
Membrane expression of PAC-1
Time frame: 3 months
Platelet activity determined by activation marker
Concentration of D-dimers, fibrin-monomers,and voln Willebrand factor
Time frame: 3 months
Changes in the coagulation cascade
Concentration in interleukin-6 and membrane expression of leukocyte activation markers
Time frame: 3 months
CHanges in parameters of inflammation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 38085214Osmancik P, Bacova B, Hozman M, Pistkova J, Kunstatova V, Sochorova V, Waldauf P, Hassouna S, Karch J, Vesela J, Poviser L, Znojilova L, Filipcova V, Benesova K, Herman D. Myocardial Damage, Inflammation, Coagulation, and Platelet Activity During Catheter Ablation Using Radiofrequency and Pulsed-Field Energy. JACC Clin Electrophysiol. 2024 Mar;10(3):463-474. doi: 10.1016/j.jacep.2023.11.001. Epub 2023 Nov 6.
- Individual participant dataSharing planned: Yes. Study protocol will be shared on demand
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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.
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation using SmartTouch radiofrequency ablation catheter and Catheter ablation using Farawave pulsed-field ablation catheter in people with Atrial Fibrillation, 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 1 inclusion and 6 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 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Membrane expression of CD62P (time frame: 3 months). The study lists 4 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 NCT05603637, which also lists 1 linked publication.
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 Feb 2023.