Atrial FibrillationLACROSSNCT04456842
Cardiovascular Registry of Atrial Fibrillation
An observational study of Atrial Fibrillation and Atrial Flutter, run by Brazilian Clinical Research Institute at 17 sites in 4 countries.
Trial summary
Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Patient Registry Data
- How many people
- 2,016 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 4 Aug 2020to 30 Sep 2024
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Atrial Fibrilation or Atrial Flutter
Who may be able to join
- Age > 18 years-old that signed informed consent;
- Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;
- If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);
Who cannot join
- Patients who did not agree to participate.
- Patients without possibility of monitoring for one year.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Argentina11 sites
Hospital Interzonal General de Agudos "Dr. José Penna"
Bahía Blanca, Buenos Aires
Hospital Italiano de La Plata
Buenos Aires, La Plata
Centro Medico Luquez
Córdoba
DIM Clínica Privada
Ramos Mejía, Buenos Aires
Prevención Cardiovascular Salta
Salta
Servicios Médicos El Castaño
San Juan
Instituto Cardiovascular San Luis
San Luis
Centro Modelo de Cardiologia
San Miguel de Tucumán, Tucumán Province
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe
Hospital Provincial Dr. José Maria Cullen
Santa Fe
Centro de Investigaciones Medicas Temperley (CIMeT)
Temperley, Buenos Aires
Mexico3 sites
Centro para el Desarrollo de la Medicina y de Asistecia Medica Especializada S.C.
Culiacán, Sinaloa
Francisco Gerardo Padilla Padilla
Guadalajara, Jalisco
Centro de Estudios Clínicos de Queretaro S.C. (CECLIQ)
Querétaro City, Querétaro
Colombia2 sites
Sociedad de Cirugia de Bogota - Hospital de San Jose
Bogotá, Cundinamarca
Fundacion Valle del Lili
Cali, Valle del Cauca Department
About this study
Official title: Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study
Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death
Read the detailed description
Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Patient Registry Data
- Keywords
- Atrial Fibrilation, Antithrombotic therapy, Atrial Flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Registry DataOther
To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.
What is being measured
The primary outcome is the main question the study is designed to answer.
INR control rate
Measured: 12 months
Oral anticoagulation discontinuation rate
Measured: 12 months
Percentage of death
Measured: 12 months
Percentage of stroke
Measured: 12 months
Percentage of systemic embolism
Measured: 12 months
Percentage of myocardial infarction
Measured: 12 months
Percentage of major bleeding
Measured: 12 months
Percentage of electrical cardioversion
Measured: 12 months
Percentage of percutaneous ablation of AF
Measured: 12 months
Percentage of atrioventricular junction ablation
Measured: 12 months
Percentage of patients that need of pacemaker implantation
Measured: 12 monts
Percentage of other cardiovascular hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start4 Aug 2020
- Primary completion13 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,016 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato D. Lopes, MD, PhD, Study chair, Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456842
- Sponsor's protocol ID
- 001/2018
- Acronym
- LACROSS
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
de Barros E Silva PGM, Damiani L, Arantes PE, Ianof JN, Yoshida LAF, Barbosa LM, Gomez-Mesa JE, Bahit MC, Padilla FG, Dall'Orto FTC, de Los Rios Ibarra MO, Antunes M, Sanchez AO, Cartasegna L, Tramujas L, Dos Reis Saraiva Falcao SN, Hominal M, Gamba MAA, de Lima CEB, Venancio AC, Montenegro E, Muntaner JA, Almagro SM, Troiani do Nascimento C, Carneiro RM, Montana OR, Lopes RD. Registry of atrial fibrillation in Latin America: Primary results of the LACROSS study. Am Heart J. 2026 Nov;301:107514. doi: 10.1016/j.ahj.2026.107514. Epub 2026 Jun 19.
PubMed 42320706
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study
- ClinicalTrials.gov ID
- NCT04456842
- Acronym / sponsor ID
- LACROSS / 001/2018
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Atrial Fibrilation, Antithrombotic therapy, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Jul 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.
Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death
Detailed description
Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Atrial Fibrilation or Atrial Flutter
Key inclusion criteria (3 listed)
- Age > 18 years-old that signed informed consent;
- Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document;
- If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h);
Key exclusion criteria (2 listed)
- Patients who did not agree to participate.
- Patients without possibility of monitoring for one year.
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 |
|---|---|---|
| Patient Registry DataTo set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death. | Other | – |
Primary outcome
INR control rate
Time frame: 12 months
Oral anticoagulation discontinuation rate
Time frame: 12 months
Percentage of death
Time frame: 12 months
Percentage of stroke
Time frame: 12 months
Percentage of systemic embolism
Time frame: 12 months
Percentage of myocardial infarction
Time frame: 12 months
Percentage of major bleeding
Time frame: 12 months
Percentage of electrical cardioversion
Time frame: 12 months
Percentage of percutaneous ablation of AF
Time frame: 12 months
Percentage of atrioventricular junction ablation
Time frame: 12 months
Percentage of patients that need of pacemaker implantation
Time frame: 12 monts
Percentage of other cardiovascular hospitalization
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Derived from this study: PubMed 42320706de Barros E Silva PGM, Damiani L, Arantes PE, Ianof JN, Yoshida LAF, Barbosa LM, Gomez-Mesa JE, Bahit MC, Padilla FG, Dall'Orto FTC, de Los Rios Ibarra MO, Antunes M, Sanchez AO, Cartasegna L, Tramujas L, Dos Reis Saraiva Falcao SN, Hominal M, Gamba MAA, de Lima CEB, Venancio AC, Montenegro E, Muntaner JA, Almagro SM, Troiani do Nascimento C, Carneiro RM, Montana OR, Lopes RD. Registry of atrial fibrillation in Latin America: Primary results of the LACROSS study. Am Heart J. 2026 Nov;301:107514. doi: 10.1016/j.ahj.2026.107514. Epub 2026 Jun 19.
- Individual participant dataSharing planned: Yes
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Renato D. Lopes, MD, PhD study chair
Instituto Brasileiro de Pesquisa Thomaz de Carvalho - BCRI
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Brazilian Clinical Research Institute at 17 sites in 4 countries.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Argentina, Mexico, Colombia, Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INR control rate (time frame: 12 months). The study lists 12 primary outcomes in all. 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 NCT04456842, which also lists 1 linked publication.
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 4 Oct 2024.