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CompletedNCT03795883Updated Mar 10, 2022

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

An observational study in Atrial Fibrillation, Thrombosis Cardiac and Left Atrial Thrombosis, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Rambam Health Care Campus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
47
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Thrombosis Cardiac
  • Left Atrial Thrombosis

Keywords

  • Thrombin generation
  • Calibrated automated thrombogram
  • Atrial fibrillation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 47 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Age above 18
  • Pulmonary vein ablation, SVT ablation or mitral clip.
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Left atrial thrombus
  • Pregnancy
  • Active malignancy
  • Thrombophilia
  • Anticoagulants 24 hours before procedure
  • Active infectious disease
  • Chronic kidney disease (eGFR\<30)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
47 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)

    ETP (endogenous thrombotic potential) nM\*min

    Time frame: 1 Day

  2. Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)

    Peak height nM

    Time frame: 1 Day

  3. Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)

    Lag time in minutes

    Time frame: 1 Day

  4. Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)

    Time to peak in minutes

    Time frame: 1 Day

Secondary outcomes

  1. The 1 year incidence of thromboembolic events

    Time frame: 1 Year

  2. The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)

    Time frame: 1 Days

07

Study locations

1 site
  • Rambam Health Care Campus
    Haifa, 31999, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03795883
Lead sponsor
Rambam Health Care Campus
Responsible party
Adi Elias MD (Resident Physician at Cardiology Department, Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Jan 8, 2019
Start date
Feb 1, 2019
Primary completion
Dec 31, 2021
Completion
Mar 9, 2022
Last update
Mar 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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