Coagulation Activity and Thrombogenesis in Patients With Atrial Fibrillation

NCT02451254 | Completed

• 1 other identifier: TASMC-15-EC-0142-15-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Atrial fibrillation confers up to 5-fold increased risk of stroke in the absence of valvular heart disease. Although epidemiological studies have linked various clinical and echocardiographic risk factors to stroke, the exact mechanism of increased risk of stroke in AF remains poorly understood. Previous reports have suggested that loss of effective atrial contraction because of AF is associated with thrombogenesis. Microthrombi are most likely to form in the left atrial appendage. In contrast, intravascular thrombotic events in patients without AF are generally associated with abnormalities of vascular endothelial function and/or the coagulation system. On the assumption that more than 90% of all cardiac thrombi in patients with AF form in the LA appendage, and the fact that thrombi have been identified in 15-20% of patients with AF who have clinical risk factors for ischemic stroke, it has been deemed to be "our most lethal attachment". Administration of anticoagulant therapy is generally thought to be necessary as a preventive measure for patients at high risk of thromboembolism, but data indicating inadequate implementation of this highly effective therapy\]. Several studies have found regional differences in platelet activation and hypercoagulability in the LA compared with systemic circulation in patients with valvular and nonvalvular AF, suggesting local contributing factors. Animal studies have demonstrated increased platelet activation and endothelial dysfunction with acute AF. The ability of antiplatelet agents to reduce the risk of cardioembolic events in AF suggests that platelets may contribute to the pathophysiology. Platelet activation occurs with AF and rapid atrial pacing, providing a possible mechanistic link. Other biomarkers that have proposed to improve the prediction of thromboembolotic events in this patient population include von Willebrand factor and D-dimer and cerebral imaging. A comprehensive understanding of the pathophysiological sequence leading to thrombus formation in the LAA of patients with AF could be helpful to characterize those at high risk for thromboembolic events, and subsequently to optimize the management of high risk patients.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Thrombotic biomarkers in AF patients

  comparison of blood sampling from the LA, RA, and systemic circulation in AF patients

  12 months

Study Arms (2)

Atrial Fibrillation

EXPERIMENTAL

Atrial Fibrillation patients electively admitted for circumferential ablation of the pulmonary veins.

Procedure: circumferential ablation

control

ACTIVE COMPARATOR

patients electively admitted for SVT ablation

Device: SVT ablation

Interventions

circumferential ablation PROCEDURE

circumferential ablation of the pulmonary veins

Atrial Fibrillation

SVT ablation DEVICE

SVT ablation

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AF patients from cardiology department in our institution electively admitted for circumferential ablation of the pulmonary veins.
• Control - patients from cardiology department in our institution electively admitted for SVT ablation.

You may not qualify if:

• Intra- and extra-cardiac shunts

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (2)

Tel Aviv medical center

Tel Aviv, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehud Chorin, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: December 1, 2015
• Primary Completion: June 12, 2018
• Study Completion: May 22, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)