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.

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31999
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study group:Participants with atrial fibrillation admitted to pulmonary vein ablation Control group: Participant without atrial fibrillation admitted to left sided SVT ablation or Mitral clip.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants with atrial fibrillation; Patients with atrial fibrillation admitted for standard pulmonary vein ablation.
Participants without atrial fibrillation; Patients without atrial fibrillation admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Thrombin generation; Calibrated automated thrombogram
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thrombosis
• Other Study ID Numbers: RMB CTIL-0216-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No