AzTrials
AzTrials

Atrial FibrillationNCT02451254

Coagulation Activity and Thrombogenesis in Patients With Atrial Fibrillation

A study testing circumferential ablation and SVT ablation in people with Atrial Fibrillation, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
circumferential ablation and SVT ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesIsrael
Study dates
1 Dec 2015to 22 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1.Intra- and extra-cardiac shunts

Trial locations and contacts

2 sites in 1 country.

Israel2 sites
  • Tel Aviv medical center

    Tel Aviv

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

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.

Read the detailed description

Aim: To compare biomarkers and mediators associated with arterial and venous thrombosis from blood sampling from the LA, RA, and systemic circulation in patients with AF.

Methods and population: A prospective trial of patients who undergo circumferential ablation of the pulmonary veins. For the clinical procedure, a conventional transeptal puncture is performed. In the beginning of the procedure, following transeptal puncture, and before intravenous administration of unfractionated heparin (bolus of 50-100 IU/kg), blood samples will simultaneously be collected from the peripheral femoral venous sheath, arterial line, right atrial sheath, and LA sheath. Samples from the RA and LA will be collected with the sheath positioned in the midchamber and close to the appendages. Each Patient will provide up to 40ml of blood for the following blood tests: (1) Blood count. (2) Fibrinogen (3) Factor VIII (4) D-dimer (5) P-selectin (6) von Willebrand factor (7) TEG - Thromboelastography Serum and plasma samples will be stored for future tests.

Being tested
circumferential ablation, SVT ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • circumferential ablationProcedure or surgery

    circumferential ablation of the pulmonary veins

  • SVT ablationDevice

    SVT ablation

Study groups in NCT02451254
Study groupRoleWhat they receive
Atrial FibrillationExperimentalAtrial Fibrillation patients electively admitted for circumferential ablation of the pulmonary veins.
Receives: Procedure: circumferential ablation
controlActive comparatorpatients electively admitted for SVT ablation
Receives: Device: SVT ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thrombotic biomarkers in AF patients

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion12 Jun 2018
  4. Study completion22 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02451254
Sponsor's protocol ID
TASMC-15-EC-0142-15-CTIL
Status last verified
May 2019
First submitted
19 May 2015
Last updated
24 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing circumferential ablation and SVT ablation in people with Atrial Fibrillation, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thrombotic biomarkers in AF patients (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in