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

June 4, 2020 updated by: Dr Carlo Lavalle

Italian Registry In the Setting of AF Ablation With Rivaroxaban

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

IRIS study is an Italian, multicenter, prospective and non-interventional study aimed to observe the safety and efficacy of uninterrupted or shortly interrupted catheter ablation procedure with Rivaroxaban in nonvalvular atrial fibrillation (NVAF) patients in real-world clinical practice.

250 patients treated with rivaroxaban undergoing AF-ablation procedure are expected to be enrolled in two years. 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. Also the decision on the ablation technique and energy used during the procedure (radiofrequency catheter ablation or Cryoballoon Ablation) is up to the investigators.

Because this study is intended to assess the use of rivaroxaban in routine real-world clinical practice, study protocol will not interfere with the clinical management of patients or with the prescribing behaviors of attending physicians.

IRIS study will include all consenting patients and collect data at the following time points:

  • One inclusion/exclusion visit at the hospital (during hospitalization or outpatient visit);
  • Ablation procedure in hospital;
  • One-month follow-up visit.

Baseline Data

The Following information will be collected for each enrolled patient at the initial visit:

  • Patient demographics (date of birth, gender, ethnic origin, height/weight)
  • Previous therapies or interventions to treat AF, including cardioversion and ablation
  • AF characteristics (paroxysmal or persistent)
  • Cardiovascular risk factors, concomitant cardiovascular diseases and other diseases/conditions
  • Concomitant medications
  • Stroke and bleeding risk profiles based on CHA2DS2 (Congestive heart failure, Hypertension, Age, Diabetes Mellitus, Stroke) - VASc27 (Vascular disease, Age, Sex) score, and HAS (Hypertension, Abnormal renal and liver function, Stroke) - BLED28 (Bleeding, Labile International Normalized Ratio, Elderly, Drugs or alcohol) score.
  • Data on the AF-related diagnostic assessment, including electrocardiographic assessment, blood biochemistry, echocardiography and other diagnostic procedures, if performed as part of routine care
  • Inform consent signature

Ablation procedure

  • Type of Ablation procedure
  • Activated Clotting Time (ACT)
  • Adverse Event (AE)/Serious Adverse Event (SAE)
  • Major complication events

Follow-Up Data Follow-up data at 1 month will be collected for all patients.

The following information will be obtained by phone or during a visit to the center for each enrolled patient:

  • Any bleedings event described in the study protocol;
  • Major complications described in the study protocol;
  • Adherence to Non-VKA Oral Anticoagulant (NOACs) therapy,
  • Concomitant medications;
  • Concomitant procedures;
  • AE/SAE.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Dipartimento di Scienze Cardiovascolari, Respiratorie, Nefrologiche, Anestesiologiche e Geriatriche.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Lavalle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who do not agree with study inclusion;
  • Impossible to Non-VKA Oral Anticoagulant (NOAC);
  • Moderate to severe hepatic impairment;
  • Pregnancy or lactation;
  • Creatinine Clearance (CrCl) < 15 ml/min.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Rivaroxaban therapy for at least 4 weeks.
Procedure: Catheter ablation
Radiofrequency catheter ablation or cryoballoon ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of thromboembolic and bleeding events.
Time Frame: 30 ± 5 days after the catheter ablation procedure.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness endpoints
Time Frame: 30 days after the catheter ablation procedure.

The secondary endpoint is the incidence of any of the below listed events within the first 30 days after the catheter ablation procedure:

  • Stroke;
  • Transient ischemic attack (TIA);
  • Myocardial infarction (MI);
  • Venous Thromboembolism (VTE).
30 days after the catheter ablation procedure.
Ablation procedure endpoints
Time Frame: 30 days after the catheter ablation procedure.

The secondary endpoint is the incidence of any of the below listed events within the first 30 days after the catheter ablation procedure:

  • Death;
  • Tamponade;
  • Total femoral pseudoaneurysm;
  • Total artero-venous fistulae.
30 days after the catheter ablation procedure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activated Clotting Time (ACT)
Time Frame: During the ablation procedure.
ACT evaluation to assess procedural heparin dose requirement during the ablation procedure.
During the ablation procedure.
Study medication adherence
Time Frame: At baseline and after 30 days.
The study medication adherence is evaluated counting pills from the blister at baseline and after 30 days.
At baseline and after 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Carlo Lavalle

Collaborators

Istituto Nazionale per le Ricerche Cardiovascolari (INRC)

Investigators

  • Principal Investigator: Carlo Lavalle, Dr, Policlinico Umberto I

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (ACTUAL)

March 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It has been planned to share all Individual Participant Data (IPD) that underlie results in a publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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