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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795883
• Other study ID #: RMB CTIL-0216-18
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: March 9, 2022

Study information

• Verified date: March 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 9, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Left Atrial Thrombosis
• Thrombosis
• Thrombosis Cardiac

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)	ETP (endogenous thrombotic potential) nM*min	1 Day
Primary	Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)	Peak height nM	1 Day
Primary	Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)	Lag time in minutes	1 Day
Primary	Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)	Time to peak in minutes	1 Day
Secondary	The 1 year incidence of thromboembolic events		1 Year
Secondary	The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)		1 Days