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Clinical Trials/NCT03795883
NCT03795883
Completed
Not Applicable

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

Rambam Health Care Campus1 site in 1 country47 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Rambam Health Care Campus
Enrollment
47
Locations
1
Primary Endpoint
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
March 9, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adi Elias MD

Resident Physician at Cardiology Department, Principal Investigator

Rambam Health Care Campus

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)

Time Frame: 1 Day

Peak height nM

ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)

Time Frame: 1 Day

ETP (endogenous thrombotic potential) nM\*min

Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)

Time Frame: 1 Day

Lag time in minutes

Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)

Time Frame: 1 Day

Time to peak in minutes

Secondary Outcomes

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

Study Sites (1)

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