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OpenTrials
Completed

NCT Number: NCT04456842

Cardiovascular Registry of Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Interzonal General de Agudos "Dr. José Penna", Bahía Blanca, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);

Exclusion criteria

  • Patients who did not agree to participate.
  • Patients without possibility of monitoring for one year.

Treatment and study plan

Patient Registry Data

Other

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.

Primary outcomes

  1. INR control rate

    Time frame: 12 months

  2. Oral anticoagulation discontinuation rate

    Time frame: 12 months

  3. Percentage of death

    Time frame: 12 months

  4. Percentage of stroke

    Time frame: 12 months

  5. Percentage of systemic embolism

    Time frame: 12 months

  6. Percentage of myocardial infarction

    Time frame: 12 months

  7. Percentage of major bleeding

    Time frame: 12 months

  8. Percentage of electrical cardioversion

    Time frame: 12 months

  9. Percentage of percutaneous ablation of AF

    Time frame: 12 months

  10. Percentage of atrioventricular junction ablation

    Time frame: 12 months

  11. Percentage of patients that need of pacemaker implantation

    Time frame: 12 monts

  12. Percentage of other cardiovascular hospitalization

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Brazilian Clinical Research Institute

Other

Registry information

Official study title

Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study

Acronym: LACROSS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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