NCT03795883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

December 30, 2018

Last Update Submit

March 9, 2022

Conditions

Atrial FibrillationThrombosis CardiacLeft Atrial Thrombosis

Keywords

Thrombin generationCalibrated automated thrombogramAtrial fibrillation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31999, Israel

Location

Related Publications (1)

  • 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.

    PMID: 37063762DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ten cc of blood will be collected from each heart chamber (Left atrium, Left atrial appendage, Right atrium, Right ventricle) and peripheral vein

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician at Cardiology Department, Principal Investigator

Study Record Dates

First Submitted

December 30, 2018

First Posted

January 8, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2021

Study Completion

March 9, 2022

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)