Recurrence Clinical Trial
Official title:
Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation
This is a prospective, single-arm study conducted in University Hospital of Split, Department of Cardiology. Patients treated with PFA for symptomatic paroxysmal atrial fibrillation will be asked to participate in the study. An implantable loop recorder (ILR) will be placed immediately after the PFA procedure for rhythm monitoring. Early recurrences will be subsequently divided into very early recurrences (up to 1 month post-procedure) and early recurrences (1-3 months post-procedure). Late recurrences will be defined as those 3 to 12 months post-procedure. Patients will be monitored routinely through follow up visits during which ILR will be interrogated and eventual symptoms will be assessed. Follow-up visits will be scheduled 1, 3, 6, 12 months post-procedure. Median follow-up will be 12 months. Data for the study will be obtained from a loop monitor to assess the arrhythmia burden during follow-up visits in the University Hospital of Split Arrhythmia Clinic.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 17, 2024 |
Est. primary completion date | May 17, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age >18 - Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days) - Willing and able to provide informed consent. Exclusion Criteria: - Any known contraindication to AF ablation or anticoagulation. - History of previous left atrial ablation or surgical treatment. - Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance. - Asymptomatic AF patients, persistent AF, permanent AF patients. - History of clotting or bleeding disease or cryoglobulinemia. - Pregnant or lactating. - Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population. |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Center Split | Split | Splitsko-dalmatinska |
Lead Sponsor | Collaborator |
---|---|
University of Split, School of Medicine |
Croatia,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with AF recurrence 3-12 months post-procedure | Number of participants with AF recurrence 3-12 months post-procedure (AF burden defined by loop recorder findings) | 12 months | |
Secondary | Adverse event rate | Adverse event rate defined as any untoward medical occurrence, unintended disease or injury related to all aspects of the ablation procedure (death, air embolism, myocardial infarction, stroke, esophageal injury, PV stenosis, puncture site hematoma, vascular lesions). | 12 months | |
Secondary | Number of patients with very early AF recurrence (within 1 month post procedure) | Number of patients with very early AF recurrence (within 1 month post procedure) | 12 months |
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