Italian Registry In the Setting of AF Ablation With Rivaroxaban (IRIS)

NCT04315974 | Unknown

• 1 other identifier: IRIS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of IRIS study is to observe the safety and efficacy of Rivaroxaban in subjects undergoing catheter ablation for atrial fibrillation (AF) in real-world clinical practice. The transcatheter ablation of AF is now considered an essential therapeutic strategy in the management of patients with this arrhythmia. In fact, it is known how fibrillating patients have a greater risk to develop thromboembolic phenomena; this risk can also increase during ablation (risk intrinsically with the procedure), therefore a careful anti-coagulant therapy is fundamental to avoid the formation of new thrombus and their dissemination through blood circulation. The use of direct oral anti-coagulants (DOAC) in the fibrillating patient has been revealed a more safe and effective approach if compared with the standard therapy (direct vitamin K antagonists, VKA). In the specific case of the Rivaroxaban, several experimental trials have shown how the uninterrupted administration of the drug before the ablation procedure is safe and valid. However, little information related to its use in the daily clinical assistance activity is still known and no real-life data are available for the Italian context. Moreover, in Italy the uninterrupted strategy is not commonly used, and physicians often adopt the short interruption strategy. Thus, the IRIS registry is aimed to collect new real-life data by collecting not only information regarding the effectiveness and safety of the drug, but also regarding the type of strategy (short interruption or uninterrupted strategy) used by the Italian centers participating to this study.

Conditions

Atrial Fibrillation

Keywords

Catheter ablation; Rivaroxaban; Real-world clinical practice; Italian registry; Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of thromboembolic and bleeding events.

  Thromboembolic events: * Ischemic stroke; * Vascular death. Major bleeding events: * Fatal bleeding; * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; * Bleeding causing a fall in hemoglobin level of 20 g L-1 or more, or leading to transfusion of two or more units of whole blood or red cells. Non-major clinically relevant bleeding events: overt bleeding not meeting the criteria for major bleeding but associated with medical intervention.

  30 ± 5 days after the catheter ablation procedure.

Secondary Outcomes (2)

• Effectiveness endpoints

  30 days after the catheter ablation procedure.

• Ablation procedure endpoints

  30 days after the catheter ablation procedure.

Other Outcomes (2)

• Activated Clotting Time (ACT)

  During the ablation procedure.

• Study medication adherence

  At baseline and after 30 days.

Study Arms (1)

Nonvalvular atrial fibrillation patients (NVAF)

Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure.

Drug: Rivaroxaban; Procedure: Catheter ablation

Interventions

Rivaroxaban DRUG

Rivaroxaban therapy for at least 4 weeks.

Nonvalvular atrial fibrillation patients (NVAF)

Catheter ablation PROCEDURE

Radiofrequency catheter ablation or cryoballoon ablation.

Nonvalvular atrial fibrillation patients (NVAF)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation (AF) diagnosis undergoing ablation procedure. 250 patients treated with rivaroxaban undergoing AF-ablation procedure will be enrolled. The patients can arrive already taking rivaroxaban or, if they are naïve, the investigators will start the therapy and taking rivaroxaban for at least 4 weeks. The decision to prescribe rivaroxaban is under discretion of the treating physician, including the dose and duration of therapy.

You may qualify if:

• Suitable for anticoagulant therapy and catheter ablation;
• Scheduled for Non Valvular Atrial Fibrillation (NVAF) catheter ablation;
• Paroxysmal or persistent NVAF;
• Patient naïve or in therapy with Rivaroxaban;
• Written informed consent.

You may not qualify if:

• Impossible to Non-VKA Oral Anticoagulant (NOAC);
• Moderate to severe hepatic impairment;
• Pregnancy or lactation;
• Creatinine Clearance (CrCl) \< 15 ml/min.

Sponsors & Collaborators

• Dr Carlo Lavalle: lead
• Istituto Nazionale per le Ricerche Cardiovascolari (INRC): collaborator

Study Sites (1)

Azienda Ospedaliero-Universitaria Policlinico Umberto I - Dipartimento di Scienze Cardiovascolari, Respiratorie, Nefrologiche, Anestesiologiche e Geriatriche.

Roma, 00161, Italy

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Carlo Lavalle, Dr

  Policlinico Umberto I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlo Lavalle, Dr

CONTACT

+39335376901; carlolavalle@yahoo.it

Michele Magnocavallo, Dr

CONTACT

+393284923711; michelefg91@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director at the Department of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: May 15, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 5, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)