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Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission

Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05151523
Enrollment
100
Registered
2021-12-09
Start date
2022-01-01
Completion date
2026-12-01
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, intensive care unit

Brief summary

The Primary Objective of the study is to establish the One-year recurrence rates of atrial fibrillation (AF) following new-onset atrial fibrillation during intensive care unit (ICU) admission. The Secondary Objective is a composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF. The prevalence and recurrence rates of AF will be divided into sub-groups based on primary ICU admission diagnosis. All-cause mortality.

Detailed description

Patients will be screened for atrial fibrillation during hospitalization in the intensive care unit and will be followed until discharge. Once discharged home or to a rehabilitation center, they will be invited to a routine follow-up clinic at RMC cardiology institute 4-6 weeks after hospital discharge. During the clinic visit, patients will be recruited to the study follow-up plan. The follow-up plan will consist of 3 clinical visits at 4-6 weeks, 6-months and 1 -year after discharge. The follow-up program will include a comprehensive screening for symptomatic and asymptomatic atrial fibrillation events as following: Patients will be provided with a home cellular-digital 12-lead ECG transmitter. They will be instructed to conduct routine weekly transmission in order to record asymptomatic events as well as to transmit at any time they suspect an event/feel symptoms (palpitations). Home routine testing will be initiated and guided by a telephone call from a medical monitoring center. A blinded, independent, on-call medical professional team will analyze the received ECG. A 48-hour Holter ECG will be performed at 6 months and 12 months after ICU discharge Clinical visits will include 12 leads ECG, physical examination, vital signs, symptoms evaluation for suspected AF events, questioning for hospital admissions, or any other documented AF event. Patients will be asked to perform echocardiography as part of their clinical evaluation. For both the study and control group, documented AF events will be managed according to physician discretion based on clinical practice and guidelines. Long-term follow-up- 3 years- data regarding recurrent events of AF, hospitalization due to thromboembolic events, and mortality will be evaluated by telephone call or by matching patient identification numbers with the Israeli National Population Register.

Interventions

None listed

Sponsors

Katia Orvin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted to ICU over 24 hours * Diagnosed with new-onset atrial fibrillation * The patient survived the index hospitalization and was discharged home/ to a rehabilitation center.

Exclusion criteria

• Previously documented atrial fibrillation

Design outcomes

Primary

MeasureTime frameDescription
Recurrence rates of atrial-fibrillation following new-onset atrial-fibrillation during intensive care unitOne-yearA positive ECG or Holter test for atrial fibrillation will be regarded as recurrence.

Secondary

MeasureTime frameDescription
Major adverse cardiovascular events3-yearsA composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF.
Recurrence rates of atrial-fibrillation3-yearsThe prevalence and recurrence rates of atrial-fibrillation divided into sub-groups based on primary ICU admission diagnosis.
All-cause mortality3-yearsAll-cause mortality will be monitored on clinical flow-up.

Contacts

Primary ContactKatia Orvin, M.D
katiaorvin@gmail.com+972548001942
Backup ContactLIOR FISHER, M.D
fisherlior1@gmail.com+972547440708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026