Cardiac ArrhythmiaAtrial FibrillationPulsed Field Ablation
Investigational drug(s) / intervention(s)
Pulsed Field ablation: Ablation to treat atrial fibrillation
Pulsed Field ablation: Ablation to treat atrial fibrillation: Pulsed Field Ablation
Study summary
RESET-PFA 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 kinds 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 10 clinical and procedural parameters predicting a repeat ablation procedure after the blanking period in patients that had undergone an AF ablation with pulsed field ablation through a standard of care pathway.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with an indication to a pulsed-field ablation procedure of Atrial Fibrillation according to current international and local guidelines (and future revisions), existing IFU or per physician discretion
* Patients who are willing and capable of providing informed consent, participating in all testing at an approved clinical investigational center or such consent will be provided by a legal representative, if required by local law or regulation.
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.
Primary outcome measure(s)
Title: Predictive Value of Procedural Workflow Parameters for Repeat Ablation — Index procedure through 12-month follow-up Association between specific procedural variables during the index procedure (e.g., number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with each procedural variable of the index procedure (number of PFA applications per vein, lesion validation method, total procedure time, voltage and activation map characteristics). All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.
Predictive Value of Baseline Clinical Characteristics for Repeat Ablation — 12 months post-index ablation Association individual baseline characteristics (e.g., age, sex, AF type, history of cardiac comorbidities, antiarrhythmic therapy) as potential predictors of repeat ablation procedures and pulmonary vein isolation durability. Pulmonary vein isolation status will be assessed by electro-anatomical mapping systems in the repeat ablation procedure. The incidence of patients with isolated/not isolated pulmonary veins will be correlated with baseline characteristics of the patient. All variables will be assessed individually and by multivariable logistic regression to establish odds ratio values.
Trial sites (1)
Facility
City
Region
Status
Unidad de Arritmias. Departamento de Cardiología. Hospital Universitario Lozano Blesa.
Zaragoza
Zaragoza
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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