Cardiac ArrhythmiaATHENANCT05617456
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
An observational study of Cardiac Arrhythmia and Atrial Fibrillation, run by Giulio Zucchelli at 1 site in Italy.
Trial summary
ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Arrhythmia, Atrial Fibrillation
- What is being tested?
- AF ablation
- Type of treatment
- Surgery or procedure
- How many people
- 4,100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients, clinically indicated for AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information
Who may be able to join
- Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
- Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
- Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.
Who cannot join
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
- Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
- Life expectancy ≤ 12 months per physician judgment.
- Unrecovered/unresolved Adverse Events from any previous invasive procedure;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa
Giulio Zucchelli, g.zucchelli@ao-pisa.toscana.it
About this study
Official title: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study
ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected.
The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 20 clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Read the detailed description
Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about 3% of the adult population and a 2.3-fold rise is expected, owing to extended longevity in the general population and intensifying search for undiagnosed AF. Despite therapeutic advancements, AF remains one of the major causes of stroke, heart failure and sudden death and constitutes a significant burden for the health system.
AF catheter ablation is a well-established treatment for the prevention of AF recurrences. While several ablation strategies have been claimed to be effective, the standard approach to the treatment of paroxysmal AF (PAF) and non-longstanding persistent AF is pulmonary vein isolation (PVI).
Worldwide catheter ablation is increasingly being performed in AF patients. The clinical approach to catheter ablation today reflects a range in operator training and workflow preferences for different types of AF ablation procedures. More structured characterization and treatment have been proposed in order to better individualize AF treatments to reflect the highly individualized AF disease state. In important ways, however, the procedure remains relatively unchanged and is constrained by a somewhat limited set of diagnostic and therapeutic modalities. These constraints are further compounded by incoherence in an understanding of clinically meaningful endpoints for intervention and particularly catheter ablation. New technologies present EPs with greater choice and the potential for greater understanding, and it is of paramount importance to identify which patient will benefit most from a specific ablation technology and approach.
To date, several predictors of recurrence have been identified in various studies. Increasing age is a prominent AF risk factor, but increasing burden of other comorbidities including hypertension, diabetes mellitus, heart failure (HF), coronary artery disease (CAD), chronic kidney disease (CKD), obesity, and obstructive sleep apnoea (OSA) have been demonstrated to be also important; modifiable risk factors are potent contributors to AF development and progression. However, not one of these clinical parameters is able to predict arrhythmia recurrences at a high level of evidence and the only clinical parameter that demonstrated a potential link to AF recurrence was AF type. A possible explanation of these results is that the studies on AF ablation are extremely heterogeneous regarding patient selection, patient characteristics, follow-up, variation in most of the clinical variables and procedural features. This variability claims for a structured data collection that possibly overcomes intrinsic limitation of a conventional, retrospective data collection in a multicenter, standard of care fashion. Identifying upfront individuals at higher risk of developing AF in the community could facilitate targeting of preventive interventions and screening programs for early AF detection, for example in high-risk subgroups such as post-stroke patients.
In addition, although ablative treatment has been extensively evaluated in specific patient subgroups and in controlled clinical trials, information derived from clinical practice, and in particular regarding long-term outcome, is generally few and fragmented, also lacking a large cohort of prospective and multicenter study that can confirm the results of scientific research in the "real world". To date, in fact, in clinical practice registries, a limited amount of information is available about indications, acute and long-term results and complications. It is therefore of the utmost importance to evaluate the actual management of patients undergoing ablation, so as to be able to assess the trends in the therapeutic approach and potentially identify critical issues that may be subject to improvement.
The primary objective of the study is the determination of a series of clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Secondary objectives of the study are: percentage of patients free from any clinical atrial arrhythmias, evaluation of acute procedural success, correlation between acute success and medium- long-term success, evaluation of the proportion of patients who will be asymptomatic during follow-up, patient reported outcomes, rate of clinical atrial fibrillation recurrence during follow up, rate of occurrence of other arrhythmias during follow-up, association between occurrence of atrial arrhythmias and therapy adoption and patient' selection, association between ECG characteristics before / after ablation and its variations and patients' outcome, estimation of costs associated with the use of health care resources, rate of the adverse events associated with the primary ablation procedure and overall procedure time.
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation
- Being tested
- AF ablation
- Keywords
- Catheter ablation, Arrhythmias, Atrial fibrillation, Mapping system, Single-shot ablation
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablationProcedure or surgery
Patients with standard indications to AF ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline patient's characteristic (clinical history and drug therapy) and procedural measures for subjects undergoing catheter ablation
The primary outcome of this study measures the baseline patient's characteristics (clinical history and drug therapy) and electro-anatomical variables derived from the ablation approach (e.g. evaluation of voltage and activation maps, lesion validation, procedural workflow) as potential predictors of documented atrial arrhythmias, that will be evaluated at 12 months. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for >30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
Measured: 12 months
Secondary outcomes (11)
Acute procedural success of AF ablation
This secondary outcome measures the percentage of acute procedural success. The acute success of the AF ablation is verified by: the completion of the necessary ablation application(s), the validation of ablation through appropriate technique(s) and, when applicable, the termination of the primary arrhythmia.
Measured: within 30 minutes after ablation procedure
Number and percentage of patients with clinical atrial arrhythmia recurrences in the mid-term
This secondary outcome is to measure the percentage of patients with documented arrhythmias after 12- months from the procedure
Measured: 12 months
Number and percentage of patients with clinical atrial arrhythmia recurrences in the long- and very long- term
This secondary outcome is to measure the percentage of patients with documented arrhythmias after 24-, 36- and 60- months from the procedure
Measured: 60 months
Procedural ablation parameters
This secondary outcome measures the radiofrequency delivery time, the total ablation time, the fluoroscopy time, acquisition time, number of points per map, cardiac area and volume acquired from the maps
Measured: Intraoperative
Patient management parameters
This secondary outcome evaluates the patient management before, during and after the ablation procedure in clinical practice (e.g. management of anticoagulant and antiarrhythmic drug therapy, patient's compliance, sedative drugs sparing)
Measured: 7 days after the procedure
Rate of adverse events and complications during procedure and follow up
This secondary outcome measures the rate of the adverse events that occurs during the procedure and after 12 months
Measured: 12 months for adverse events during follow up and intraoperative for acute adverse events
Estimate costs related to the use of health care resources
This secondary outcome measures the resource consumption and the associated costs in term of ablation procedures, follow-up, management of complication and health care resources utilization
Measured: 12 months
Patient reported outcomes: EQ-5D-5L
This secondary outcome measures patient reported outcomes through specific symptom scale questionnaire: EQ-5D-5L score will be obtained as the sum of units on the questionnaire's scale
Measured: 12 months
Patient reported outcomes: EHRA Score of AF-related Symptoms
AF related symptoms and symptom burden will be measured through the Symptom Severity Questionnaire and EHRA Symptom Classification Score of AF-related Symptoms
Measured: 12 months
ECG characteristics before ablation
This secondary outcome measures patient ECG's characteristics before ablation to determine whether ECG complex duration (including PR and QRS duration, P wave duration and QTc duration), are associated with long-term success. The most recent 12-lead ECG prior to ablation will be used for analysis. Measurement of these parameters will be obtained at standard surface ECG recording settings of 25mm/s
Measured: 12 months
ECG characteristics after ablation
This secondary outcome measures patient ECG's characteristics after ablation to determine whether ECG complex duration (including PR and QRS duration, P wave duration and QTc duration) and their variation from pre-ablation recording, are associated with long-term success. The 12-lead ECG at hospital discharge will be used for analysis. Measurement of these parameters will be obtained at standard surface ECG recording settings of 25mm/s
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start1 Jan 2022
- Primary completionDec 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giulio Zucchelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giulio Zucchelli, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617456
- Sponsor's protocol ID
- 20977
- Acronym
- ATHENA
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anselmino M, Bianchi S, De Lucia R, Tondo C, Iacopino S, Solimene F, Rossillo A, Bertini M, Themistoclakis S, Meynet I, Russo M, Dello Russo A, Zingarini G, Bandino S, Volpicelli M, Rossi P, Bianchini L, Schillaci V, De Simone A, Scaglione M, Rovaris G, De Ferrari GM, Malacrida M, Saglietto A, Zucchelli G. Machine learning prediction of outcome following pulsed-field atrial fibrillation ablation: patient selection and risk factors. Europace. 2026 May 6;28(5):euag053. doi: 10.1093/europace/euag053.
PubMed 42134812Schiavone M, Solimene F, Dello Russo A, Bianchi S, Iacopino S, Malacrida M, Rossillo A, Themistoclakis S, Bertini M, Meynet I, Moltrasio M, Schillaci V, Casella M, Bisignani A, Colella J, Russo M, Volpicelli M, Bandino S, Zingarini G, Mitacchione G, Casula M, Fassini G, Rordorf R, De Sanctis V, De Simone A, Rovaris G, Zucchelli G, Tondo C. Pulsed field ablation for atrial fibrillation in patients with heart failure: insight from the ATHENA registrys. Europace. 2026 Mar 30;28(4):euag049. doi: 10.1093/europace/euag049. Epub 2026 Mar 17.
PubMed 41910215Ribatti V, Dello Russo A, Riva S, Malacrida M, Bianchi S, Solimene F, Iacopino S, De Simone A, Rossillo A, Pelargonio G, Zucchelli G, Maggio R, Russo M, Pecora D, Bertini M, Bandino S, Volpicelli M, Compagnucci P, De Sanctis V, Anselmino M, Rordorf R, Zingarini G, Rovaris G, Agus E, Themistoclakis S, Mitacchione G, Mea R, Valeri Y, Tondo C, Casella M. De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy. J Am Heart Assoc. 2026 Mar 3;15(5):e041873. doi: 10.1161/JAHA.125.041873. Epub 2026 Feb 12.
PubMed 41676924Moltrasio M, Iacopino S, Solimene F, Bianchi S, Schiavone M, Themistoclakis S, Rossillo A, Bertini M, Zirolia D, Volpicelli M, Zingarini G, Dello Russo A, Malacrida M, Zucchelli G, Tondo C. Termination of atrial arrhythmia and restoration of sinus rhythm during pulsed field ablation with a pentaspline catheter in patients with persistent atrial fibrillation. Europace. 2025 Jul 1;27(7):euaf144. doi: 10.1093/europace/euaf144.
PubMed 40624924Dello Russo A, Tondo C, Bianchi S, Schillaci V, Iacopino S, Casella M, Rossillo A, Maggio R, Themistoclakis S, Bertini M, Russo M, Volpicelli M, Viola G, Rordorf R, Schiavone M, Valeri Y, Colella J, Rossi P, Tundo F, Zingarini G, De Simone A, Bianchini L, Di Vilio A, Compagnucci P, Malacrida M, Zucchelli G, Solimene F. Does Age Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation? J Am Heart Assoc. 2025 May 6;14(9):e037959. doi: 10.1161/JAHA.124.037959. Epub 2025 Apr 23.
PubMed 40265595Bisignani A, Solimene F, Iacopino S, Polselli M, Dello Russo A, Tondo C, Rossillo A, Themistoclakis S, Maggio R, Russo M, Volpicelli M, Schillaci V, Schiavone M, Colella J, Casella M, Malacrida M, Zucchelli G, Bianchi S. Insight Into Early Recurrences After Pulsed-Field Ablation for Atrial Fibrillation: Results From a Multicenter Experience. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1323-1332. doi: 10.1111/jce.16670. Epub 2025 Apr 7.
PubMed 40190033Bisignani A, Schiavone M, Solimene F, Dello Russo A, Filannino P, Magnocavallo M, Tondo C, Schillaci V, Casella M, Petretta A, Rossi P, Fassini G, Rossillo A, Maggio R, Themistoclakis S, Pandozi C, Polselli M, Tundo F, Arestia A, Compagnucci P, Valente Perrone A, Malacrida M, Iacopino S, Bianchi S. National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety. J Interv Card Electrophysiol. 2024 Dec;67(9):2127-2136. doi: 10.1007/s10840-024-01835-6. Epub 2024 May 30.
PubMed 38814525Iacopino S, Colella J, Dini D, Mantovani L, Sorrenti PF, Malacrida M, Filannino P. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration. Europace. 2023 Aug 2;25(9):euad230. doi: 10.1093/europace/euad230.
PubMed 37494101
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study
- ClinicalTrials.gov ID
- NCT05617456
- Acronym / sponsor ID
- ATHENA / 20977
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation
- Keywords
- Catheter ablation, Arrhythmias, Atrial fibrillation, Mapping system, Single-shot ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Giulio ZucchelliUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 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.
ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected.
The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 20 clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Detailed description
Worldwide, atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about 3% of the adult population and a 2.3-fold rise is expected, owing to extended longevity in the general population and intensifying search for undiagnosed AF. Despite therapeutic advancements, AF remains one of the major causes of stroke, heart failure and sudden death and constitutes a significant burden for the health system.
AF catheter ablation is a well-established treatment for the prevention of AF recurrences. While several ablation strategies have been claimed to be effective, the standard approach to the treatment of paroxysmal AF (PAF) and non-longstanding persistent AF is pulmonary vein isolation (PVI).
Worldwide catheter ablation is increasingly being performed in AF patients. The clinical approach to catheter ablation today reflects a range in operator training and workflow preferences for different types of AF ablation procedures. More structured characterization and treatment have been proposed in order to better individualize AF treatments to reflect the highly individualized AF disease state. In important ways, however, the procedure remains relatively unchanged and is constrained by a somewhat limited set of diagnostic and therapeutic modalities. These constraints are further compounded by incoherence in an understanding of clinically meaningful endpoints for intervention and particularly catheter ablation. New technologies present EPs with greater choice and the potential for greater understanding, and it is of paramount importance to identify which patient will benefit most from a specific ablation technology and approach.
To date, several predictors of recurrence have been identified in various studies. Increasing age is a prominent AF risk factor, but increasing burden of other comorbidities including hypertension, diabetes mellitus, heart failure (HF), coronary artery disease (CAD), chronic kidney disease (CKD), obesity, and obstructive sleep apnoea (OSA) have been demonstrated to be also important; modifiable risk factors are potent contributors to AF development and progression. However, not one of these clinical parameters is able to predict arrhythmia recurrences at a high level of evidence and the only clinical parameter that demonstrated a potential link to AF recurrence was AF type. A possible explanation of these results is that the studies on AF ablation are extremely heterogeneous regarding patient selection, patient characteristics, follow-up, variation in most of the clinical variables and procedural features. This variability claims for a structured data collection that possibly overcomes intrinsic limitation of a conventional, retrospective data collection in a multicenter, standard of care fashion. Identifying upfront individuals at higher risk of developing AF in the community could facilitate targeting of preventive interventions and screening programs for early AF detection, for example in high-risk subgroups such as post-stroke patients.
In addition, although ablative treatment has been extensively evaluated in specific patient subgroups and in controlled clinical trials, information derived from clinical practice, and in particular regarding long-term outcome, is generally few and fragmented, also lacking a large cohort of prospective and multicenter study that can confirm the results of scientific research in the "real world". To date, in fact, in clinical practice registries, a limited amount of information is available about indications, acute and long-term results and complications. It is therefore of the utmost importance to evaluate the actual management of patients undergoing ablation, so as to be able to assess the trends in the therapeutic approach and potentially identify critical issues that may be subject to improvement.
The primary objective of the study is the determination of a series of clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.
Secondary objectives of the study are: percentage of patients free from any clinical atrial arrhythmias, evaluation of acute procedural success, correlation between acute success and medium- long-term success, evaluation of the proportion of patients who will be asymptomatic during follow-up, patient reported outcomes, rate of clinical atrial fibrillation recurrence during follow up, rate of occurrence of other arrhythmias during follow-up, association between occurrence of atrial arrhythmias and therapy adoption and patient' selection, association between ECG characteristics before / after ablation and its variations and patients' outcome, estimation of costs associated with the use of health care resources, rate of the adverse events associated with the primary ablation procedure and overall procedure time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients, clinically indicated for AF ablation, will be enrolled after signing an informed consent form and an authorization to use and disclose health information
Key inclusion criteria (3 listed)
- Patients with an indication to an ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU and per physician discretion
- Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center.
- Patients whose age is 18 years or above, and of legal age to give informed consent specific to state and national law.
Key exclusion criteria (8 listed)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
- Patients who are unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
- Patients unavailable or not willing to complete follow up visits and examination for the duration of the study at the center.
- Life expectancy ≤ 12 months per physician judgment.
- Unrecovered/unresolved Adverse Events from any previous invasive procedure;
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 |
|---|---|---|
| AF ablationPatients with standard indications to AF ablation | Procedure or surgery | – |
Primary outcome
Baseline patient's characteristic (clinical history and drug therapy) and procedural measures for subjects undergoing catheter ablation
Time frame: 12 months
The primary outcome of this study measures the baseline patient's characteristics (clinical history and drug therapy) and electro-anatomical variables derived from the ablation approach (e.g. evaluation of voltage and activation maps, lesion validation, procedural workflow) as potential predictors of documented atrial arrhythmias, that will be evaluated at 12 months. Arrhythmias in the definition are any AF, atrial flutter, or atrial tachycardia episode, continuous for >30 seconds, as recorded by any post-ablation ECG modality. Arrhythmia recurrences within the first 3 months (blanking period) are classified as early recurrences and will not be considered procedural failure
11 secondary outcomes
Acute procedural success of AF ablation
Time frame: within 30 minutes after ablation procedure
Number and percentage of patients with clinical atrial arrhythmia recurrences in the mid-term
Time frame: 12 months
Number and percentage of patients with clinical atrial arrhythmia recurrences in the long- and very long- term
Time frame: 60 months
Procedural ablation parameters
Time frame: Intraoperative
Patient management parameters
Time frame: 7 days after the procedure
Rate of adverse events and complications during procedure and follow up
Time frame: 12 months for adverse events during follow up and intraoperative for acute adverse events
Estimate costs related to the use of health care resources
Time frame: 12 months
Patient reported outcomes: EQ-5D-5L
Time frame: 12 months
Patient reported outcomes: EHRA Score of AF-related Symptoms
Time frame: 12 months
ECG characteristics before ablation
Time frame: 12 months
ECG characteristics after ablation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 42134812Anselmino M, Bianchi S, De Lucia R, Tondo C, Iacopino S, Solimene F, Rossillo A, Bertini M, Themistoclakis S, Meynet I, Russo M, Dello Russo A, Zingarini G, Bandino S, Volpicelli M, Rossi P, Bianchini L, Schillaci V, De Simone A, Scaglione M, Rovaris G, De Ferrari GM, Malacrida M, Saglietto A, Zucchelli G. Machine learning prediction of outcome following pulsed-field atrial fibrillation ablation: patient selection and risk factors. Europace. 2026 May 6;28(5):euag053. doi: 10.1093/europace/euag053.
- Derived from this study: PubMed 41910215Schiavone M, Solimene F, Dello Russo A, Bianchi S, Iacopino S, Malacrida M, Rossillo A, Themistoclakis S, Bertini M, Meynet I, Moltrasio M, Schillaci V, Casella M, Bisignani A, Colella J, Russo M, Volpicelli M, Bandino S, Zingarini G, Mitacchione G, Casula M, Fassini G, Rordorf R, De Sanctis V, De Simone A, Rovaris G, Zucchelli G, Tondo C. Pulsed field ablation for atrial fibrillation in patients with heart failure: insight from the ATHENA registrys. Europace. 2026 Mar 30;28(4):euag049. doi: 10.1093/europace/euag049. Epub 2026 Mar 17.
- Derived from this study: PubMed 41676924Ribatti V, Dello Russo A, Riva S, Malacrida M, Bianchi S, Solimene F, Iacopino S, De Simone A, Rossillo A, Pelargonio G, Zucchelli G, Maggio R, Russo M, Pecora D, Bertini M, Bandino S, Volpicelli M, Compagnucci P, De Sanctis V, Anselmino M, Rordorf R, Zingarini G, Rovaris G, Agus E, Themistoclakis S, Mitacchione G, Mea R, Valeri Y, Tondo C, Casella M. De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy. J Am Heart Assoc. 2026 Mar 3;15(5):e041873. doi: 10.1161/JAHA.125.041873. Epub 2026 Feb 12.
- Derived from this study: PubMed 40624924Moltrasio M, Iacopino S, Solimene F, Bianchi S, Schiavone M, Themistoclakis S, Rossillo A, Bertini M, Zirolia D, Volpicelli M, Zingarini G, Dello Russo A, Malacrida M, Zucchelli G, Tondo C. Termination of atrial arrhythmia and restoration of sinus rhythm during pulsed field ablation with a pentaspline catheter in patients with persistent atrial fibrillation. Europace. 2025 Jul 1;27(7):euaf144. doi: 10.1093/europace/euaf144.
- Derived from this study: PubMed 40265595Dello Russo A, Tondo C, Bianchi S, Schillaci V, Iacopino S, Casella M, Rossillo A, Maggio R, Themistoclakis S, Bertini M, Russo M, Volpicelli M, Viola G, Rordorf R, Schiavone M, Valeri Y, Colella J, Rossi P, Tundo F, Zingarini G, De Simone A, Bianchini L, Di Vilio A, Compagnucci P, Malacrida M, Zucchelli G, Solimene F. Does Age Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation? J Am Heart Assoc. 2025 May 6;14(9):e037959. doi: 10.1161/JAHA.124.037959. Epub 2025 Apr 23.
- Derived from this study: PubMed 40190033Bisignani A, Solimene F, Iacopino S, Polselli M, Dello Russo A, Tondo C, Rossillo A, Themistoclakis S, Maggio R, Russo M, Volpicelli M, Schillaci V, Schiavone M, Colella J, Casella M, Malacrida M, Zucchelli G, Bianchi S. Insight Into Early Recurrences After Pulsed-Field Ablation for Atrial Fibrillation: Results From a Multicenter Experience. J Cardiovasc Electrophysiol. 2025 Jun;36(6):1323-1332. doi: 10.1111/jce.16670. Epub 2025 Apr 7.
- Derived from this study: PubMed 38814525Bisignani A, Schiavone M, Solimene F, Dello Russo A, Filannino P, Magnocavallo M, Tondo C, Schillaci V, Casella M, Petretta A, Rossi P, Fassini G, Rossillo A, Maggio R, Themistoclakis S, Pandozi C, Polselli M, Tundo F, Arestia A, Compagnucci P, Valente Perrone A, Malacrida M, Iacopino S, Bianchi S. National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety. J Interv Card Electrophysiol. 2024 Dec;67(9):2127-2136. doi: 10.1007/s10840-024-01835-6. Epub 2024 May 30.
- Derived from this study: PubMed 37494101Iacopino S, Colella J, Dini D, Mantovani L, Sorrenti PF, Malacrida M, Filannino P. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration. Europace. 2023 Aug 2;25(9):euad230. doi: 10.1093/europace/euad230.
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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.
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 Cardiac Arrhythmia and Atrial Fibrillation, run by Giulio Zucchelli at 1 site in Italy.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Nov 2022. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulio Zucchelli, MD, PhD (+393283687691, g.zucchelli@ao-pisa.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline patient's characteristic (clinical history and drug therapy) and procedural measures for subjects undergoing catheter ablation (time frame: 12 months). 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 NCT05617456, which also lists 8 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 2022.