The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.
Sponsor study identifier
observational
47
1 country
1
Study Start
February 1, 2019
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
March 9, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2018
Actual (reported)January 8, 2019
Actual (reported)February 1, 2019
Actual (reported)December 31, 2021
Actual (reported)March 9, 2022
Actual (reported)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
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
Patients with atrial fibrillation admitted for standard pulmonary vein ablation.
Patients without atrial fibrillation admitted for standard left sided supra ventricular tachycardia ablation or patients admitted to mitral clip procedure.
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.
Rambam Health Care Campus
Haifa, 31999, Israel
Elias A, Khoury Y, Shehadeh F, Ron G, Boulos M, Nashashibi J, Zukermann R, Elias M, Gepstein L, Suleiman M. Elevated thrombin generation levels in the left atrial appendage in patients with atrial fibrillation. Res Pract Thromb Haemost. 2023 Mar 15;7(2):100127. doi: 10.1016/j.rpth.2023.100127. eCollection 2023 Feb.
Ten cc of blood will be collected from each heart chamber (Left atrium, Left atrial appendage, Right atrium, Right ventricle) and peripheral vein
47 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2018
First Posted
January 8, 2019
Study Start
February 1, 2019
Actual (reported)Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2021
Actual (reported)Study Completion
March 9, 2022
Actual (reported)Last Updated
March 10, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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