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The Thrombotic Potential of Heart Chambers in the Presence or Absence of Atrial Fibrillation.

The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03795883
Enrollment
47
Registered
2019-01-08
Start date
2019-02-01
Completion date
2022-03-09
Last updated
2022-03-10

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

Conditions

Atrial Fibrillation, Left Atrial Thrombosis, Thrombosis Cardiac

Keywords

Thrombin generation, Calibrated automated thrombogram, Atrial fibrillation

Brief summary

The investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation and compared to patients without atrial fibrillation admitted for left sided supra ventricular tachycardia or mitral clip. Thrombin generation parameters will be assessed by the calibrated automated thrombogram.

Detailed description

Atrial fibrillation is the most common arrhythmia, there is a strong correlation between atrial fibrillation and embolic stroke. In order to lower the risk for embolic stroke anticoagulation is recommended for patients with CHADS-VASC score equal or above 2. The mechanism for thrombus formation in the left atrium is thought to be caused by various factors 1. blood stasis due to the loss of atrial kick 2. endothelial dysfunction 3. blood hemostatic alteration leading to procoagulant state. Previous studies demonstrated increased thrombin generation in the left atrium in patients with atrial fibrillation, when compared to other heart chambers and when compared to control group in patients with structurally normal heart. In recent years calibrated automated thrombogram (CAT) is considered a good indicator for total thrombotic activity in hypercoagulable states. In the current study the investigators aim to test the thrombotic potential of various heart chambers including left atrium, left atrial appendage, right atrium and peripheral veins. Blood samples will be taken from the different chambers in 50 patients admitted for standard pulmonary vein ablation without changing the course of the procedure. Thrombin generation parameters will be assessed by the calibrated automated thrombogram. A control group composed of 50 patients admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure without the presence of atrial fibrillation. In addition demographic data,CHADS-VASC score, atrial fibrillation burden, echocardiographic and cardiac CT parameters will be collected.

Interventions

None listed

Sponsors

Rambam Health Care Campus
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

* Age above 18 * Pulmonary vein ablation, SVT ablation or mitral clip. * Informed consent

Exclusion criteria

* Left atrial thrombus * Pregnancy * Active malignancy * Thrombophilia * Anticoagulants 24 hours before procedure * Active infectious disease * Chronic kidney disease (eGFR\<30)

Design outcomes

Primary

MeasureTime frameDescription
ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)1 DayETP (endogenous thrombotic potential) nM\*min
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)1 DayPeak height nM
Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)1 DayLag time in minutes
Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)1 DayTime to peak in minutes

Secondary

MeasureTime frame
The 1 year incidence of thromboembolic events1 Year
The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)1 Days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026