Recruiting

Observational Study

Sponsor:

CorVita Science Foundation

Code:

NCT05978466

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.

Conditions

Atrial Fibrillation

Study ID

NCT05978466

Start date

Dec 22, 2017

Status verified date

Jan, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of valvular or non valvular atrial fibrillation
2. ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder

Exclusion Criteria:

1. Age below 18 years.
2. Clinical evidence that death within 6 months is possible
3. Inability to consent to the research or sign a consent form
4. Inability to follow up at the research clinic at least annually for continuity of AF care and management

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Recurrence of Atrial fibrillation [ Time Frame: From enrollment to 10- year study completion ]
  • Number of participants who had thrombo-embolic event [ Time Frame: From enrollment to 10- year study completion ]
  • Mortality [ Time Frame: From enrollment to 10- year study completion ]

Central Contacts and Locations

Locations

CorVita Science Foundation (NFP)

Recruiting

Chicago, Illinois, United States, 60605

Contacts

Principal Investigator:

Martin C Burke, DO

More Information

Sponsor

CorVita Science Foundation

Last update posted

Jan 18, 2024

Last verified

Jan, 2024

Keywords

  • atrial arrhythmia
  • atrial fibrillation
  • stroke
  • bleeding
  • Left Atrial Appendage Occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CorVita Science Foundation on 2024-01-18.