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Completed

NCT Number: NCT03795883

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Health Care Campus

Haifa, 31999, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

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

    Time frame: 1 Day

    ETP (endogenous thrombotic potential) nM*min

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

    Time frame: 1 Day

    Peak height nM

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

    Time frame: 1 Day

    Lag time in minutes

  4. 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

  1. The 1 year incidence of thromboembolic events

    Time frame: 1 Year

  2. The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)

    Time frame: 1 Days

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 8, 2019
Registry last updated
Mar 10, 2022

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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