Status:
UNKNOWN
Italian Registry In the Setting of AF Ablation With Rivaroxaban (IRIS)
Lead Sponsor:
Dr Carlo Lavalle
Collaborating Sponsors:
Istituto Nazionale per le Ricerche Cardiovascolari (INRC)
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
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 abl...
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 Rivaro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04315974
Start Date
May 15 2020
End Date
March 1 2022
Last Update
June 5 2020
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Dipartimento di Scienze Cardiovascolari, Respiratorie, Nefrologiche, Anestesiologiche e Geriatriche.
Roma, Italy, 00161