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

Completed

• Conditions: Atrial Fibrillation; Thrombosis Cardiac; Left Atrial Thrombosis

• Registration Number: NCT03795883
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2018-12-30
• Study First Submitted QC: 2019-01-05
• Study First Posted: 2019-01-08
• Study Start: 2019-02-01
• Primary Completion: 2021-12-31
• Status Verified: 2022-03
• Study Completion: 2022-03-09
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)	1 Day	Peak height nM
ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)	1 Day	ETP (endogenous thrombotic potential) nM\*min
Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)	1 Day	Lag time in minutes
Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)	1 Day	Time to peak in minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel