Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

Atrial Fibrillation Clinical Trial

— ATHENA  

Official title:

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice: ATHENA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617456
• Other study ID #: 20977
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 2029

Study information

• Verified date: November 2022
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Giulio Zucchelli, MD, PhD
• Phone: +393283687691
• Email: g.zucchelli[@]ao-pisa.toscana.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4100
• Est. completion date: January 2029
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia

Intervention

Procedure:
• AF ablation
Patients with standard indications to AF ablation

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Giulio Zucchelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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.	within 30 minutes after ablation procedure
Secondary	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	12 months
Secondary	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	60 months
Secondary	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	Intraoperative
Secondary	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)	7 days after the procedure
Secondary	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	12 months for adverse events during follow up and intraoperative for acute adverse events
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	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	12 months