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

NCT04315974 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2020-06-05

No results posted yet for this study

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

Interventions

DRUG

Rivaroxaban

Rivaroxaban therapy for at least 4 weeks.

PROCEDURE

Catheter ablation

Radiofrequency catheter ablation or cryoballoon ablation.

Sponsors & Collaborators

  • Istituto Nazionale per le Ricerche Cardiovascolari (INRC)

    collaborator UNKNOWN

  • Dr Carlo Lavalle

    lead OTHER

Principal Investigators

  • Carlo Lavalle, Dr · Policlinico Umberto I

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315974 on ClinicalTrials.gov