Atrial FibrillationIRISNCT04315974
Italian Registry In the Setting of AF Ablation With Rivaroxaban (IRIS)
An observational study of Atrial Fibrillation, run by Dr Carlo Lavalle at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban and Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2020to Mar 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Dipartimento di Scienze Cardiovascolari, Respiratorie, Nefrologiche, Anestesiologiche e Geriatriche.
Roma, 00161
Carlo Lavalle, +39335376901, carlolavalle@yahoo.it
Michele Magnocavallo, +393284923711, michelefg91@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban, Catheter ablation
- Keywords
- Catheter ablation, Rivaroxaban, Real-world clinical practice, Italian registry, Non-valvular Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban therapy for at least 4 weeks.
Catheter ablationProcedure or surgery
Radiofrequency catheter ablation or cryoballoon ablation.
| Study group | Role | What they receive |
|---|---|---|
| Nonvalvular atrial fibrillation patients (NVAF) | Eligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure. Receives: Drug: Rivaroxaban; Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 ± 5 days after the catheter ablation procedure.
Secondary outcomes (2)
Effectiveness endpoints
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).
Measured: 30 days after the catheter ablation procedure.
Ablation procedure endpoints
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.
Measured: 30 days after the catheter ablation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 May 2020
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Dr Carlo Lavalle
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Nazionale per le Ricerche Cardiovascolari (INRC)
- Responsible party
- Sponsor-investigator, Dr Carlo Lavalle, Azienda Policlinico Umberto I
- Investigators
- Carlo Lavalle, Dr, Principal investigator, Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315974
- Sponsor's protocol ID
- IRIS
- Acronym
- IRIS
- Status last verified
- Jun 2020
- First submitted
- 18 Mar 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It has been planned to share all Individual Participant Data (IPD) that underlie results in a publication.
Publications
Lakkireddy D, Reddy YM, Di Biase L, Vallakati A, Mansour MC, Santangeli P, Gangireddy S, Swarup V, Chalhoub F, Atkins D, Bommana S, Verma A, Sanchez JE, Burkhardt JD, Barrett CD, Baheiry S, Ruskin J, Reddy V, Natale A. Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol. 2014 Mar 18;63(10):982-8. doi: 10.1016/j.jacc.2013.11.039. Epub 2014 Jan 8.
PubMed 24412445January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PubMed 27567408Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
PubMed 28506916Nairooz R, Sardar P, Pino M, Aronow WS, Sewani A, Mukherjee D, Paydak H, Maskoun W. Meta-analysis of risk of stroke and thrombo-embolism with rivaroxaban versus vitamin K antagonists in ablation and cardioversion of atrial fibrillation. Int J Cardiol. 2015;187:345-53. doi: 10.1016/j.ijcard.2015.03.323. Epub 2015 Mar 21.
PubMed 25839640Zhao Y, Yang Y, Tang X, Yu X, Zhang L, Xiao H. New oral anticoagulants compared to warfarin for perioperative anticoagulation in patients undergoing atrial fibrillation catheter ablation: a meta-analysis of continuous or interrupted new oral anticoagulants during ablation compared to interrupted or continuous warfarin. J Interv Card Electrophysiol. 2017 Apr;48(3):267-282. doi: 10.1007/s10840-016-0221-7. Epub 2017 Jan 12.
PubMed 28078536Romero J, Cerrud-Rodriguez RC, Diaz JC, Michaud GF, Taveras J, Alviz I, Grupposo V, Cerna L, Avendano R, Kumar S, Kirchhof P, Natale A, Di Biase L. Uninterrupted direct oral anticoagulants vs. uninterrupted vitamin K antagonists during catheter ablation of non-valvular atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. Europace. 2018 Oct 1;20(10):1612-1620. doi: 10.1093/europace/euy133.
PubMed 29982383Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
PubMed 21830957Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.
PubMed 23500298Tao S, Otomo K, Ono Y, Osaka Y, Hirao T, Koura K, Manno T, Ueshima D, Shimizu S, Isobe M, Hirao K. Efficacy and safety of uninterrupted rivaroxaban taken preoperatively for radiofrequency catheter ablation of atrial fibrillation compared to uninterrupted warfarin. J Interv Card Electrophysiol. 2017 Mar;48(2):167-175. doi: 10.1007/s10840-016-0214-6. Epub 2016 Dec 9.
PubMed 27943112Dillier R, Ammar S, Hessling G, Kaess B, Pavaci H, Buiatti A, Semmler V, Kathan S, Hofmann M, Lennerz C, Kolb C, Reents T, Deisenhofer I. Safety of continuous periprocedural rivaroxaban for patients undergoing left atrial catheter ablation procedures. Circ Arrhythm Electrophysiol. 2014 Aug;7(4):576-82. doi: 10.1161/CIRCEP.114.001586. Epub 2014 Jun 26.
PubMed 24970293Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hugl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.
PubMed 25975659Aryal MR, Ukaigwe A, Pandit A, Karmacharya P, Pradhan R, Mainali NR, Pathak R, Jalota L, Bhandari Y, Donato A. Meta-analysis of efficacy and safety of rivaroxaban compared with warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation. Am J Cardiol. 2014 Aug 15;114(4):577-82. doi: 10.1016/j.amjcard.2014.05.038. Epub 2014 Jun 6.
PubMed 24998087Li W, Gao C, Li M, Wang X, Qi D, Zhang Y, Hao P, Liu J, Zhu L. Safety and efficacy of rivaroxaban versus warfarin in patients undergoing catheter ablation of atrial fibrillation: a meta-analysis of observational studies. Discov Med. 2015 Mar;19(104):193-201.
PubMed 25828523Phan K, Wang N, Pison L, Kumar N, Hitos K, Thomas SP. Rivaroxaban versus warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation: A meta-analysis. Int J Cardiol. 2015 Apr 15;185:209-13. doi: 10.1016/j.ijcard.2015.03.102. Epub 2015 Mar 10. No abstract available.
PubMed 25797679
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry In the Setting of AF Ablation With Rivaroxaban
- ClinicalTrials.gov ID
- NCT04315974
- Acronym / sponsor ID
- IRIS / IRIS
- Conditions
- Atrial Fibrillation
- Keywords
- Catheter ablation, Rivaroxaban, Real-world clinical practice, Italian registry, Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Dr Carlo LavalleUniversity, hospital or other
- Collaborators
- Istituto Nazionale per le Ricerche Cardiovascolari (INRC)
- Study start
- 15 May 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonvalvular atrial fibrillation patients (NVAF) | – | Drug: Rivaroxaban, Procedure: Catheter ablationEligible patients comprise men and women aged 18 years or older with nonvalvular atrial fibrillation diagnosis undergoing ablation procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanRivaroxaban therapy for at least 4 weeks. | Drug | Nonvalvular atrial fibrillation patients (NVAF) |
| Catheter ablationRadiofrequency catheter ablation or cryoballoon ablation. | Procedure or surgery | Nonvalvular atrial fibrillation patients (NVAF) |
Primary outcome
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.
2 secondary outcomes
Effectiveness endpoints
Time frame: 30 days after the catheter ablation procedure.
Ablation procedure endpoints
Time frame: 30 days after the catheter ablation procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Background: PubMed 24412445Lakkireddy D, Reddy YM, Di Biase L, Vallakati A, Mansour MC, Santangeli P, Gangireddy S, Swarup V, Chalhoub F, Atkins D, Bommana S, Verma A, Sanchez JE, Burkhardt JD, Barrett CD, Baheiry S, Ruskin J, Reddy V, Natale A. Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol. 2014 Mar 18;63(10):982-8. doi: 10.1016/j.jacc.2013.11.039. Epub 2014 Jan 8.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 27567408Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
- Background: PubMed 28506916Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
- Background: PubMed 25839640Nairooz R, Sardar P, Pino M, Aronow WS, Sewani A, Mukherjee D, Paydak H, Maskoun W. Meta-analysis of risk of stroke and thrombo-embolism with rivaroxaban versus vitamin K antagonists in ablation and cardioversion of atrial fibrillation. Int J Cardiol. 2015;187:345-53. doi: 10.1016/j.ijcard.2015.03.323. Epub 2015 Mar 21.
- Background: PubMed 28078536Zhao Y, Yang Y, Tang X, Yu X, Zhang L, Xiao H. New oral anticoagulants compared to warfarin for perioperative anticoagulation in patients undergoing atrial fibrillation catheter ablation: a meta-analysis of continuous or interrupted new oral anticoagulants during ablation compared to interrupted or continuous warfarin. J Interv Card Electrophysiol. 2017 Apr;48(3):267-282. doi: 10.1007/s10840-016-0221-7. Epub 2017 Jan 12.
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- Individual participant dataSharing planned: Yes. It has been planned to share all Individual Participant Data (IPD) that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Lavalle, Dr principal investigator
Policlinico Umberto I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Dr Carlo Lavalle at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Lavalle, Dr (+39335376901, carlolavalle@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thromboembolic and bleeding events. (time frame: 30 ± 5 days after the catheter ablation procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315974, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.