Atrial Fibrillation Clinical Trial
Official title:
The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.
Verified date | March 2022 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | March 9, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age above 18 - Pulmonary vein ablation, SVT ablation or mitral clip. - Informed consent Exclusion Criteria: - Left atrial thrombus - Pregnancy - Active malignancy - Thrombophilia - Anticoagulants 24 hours before procedure - Active infectious disease - Chronic kidney disease (eGFR<30) |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ETP of various heart chambers measured by the calibrated automated thrombogram (CAT) | ETP (endogenous thrombotic potential) nM*min | 1 Day | |
Primary | Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT) | Peak height nM | 1 Day | |
Primary | Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT) | Lag time in minutes | 1 Day | |
Primary | Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT) | Time to peak in minutes | 1 Day | |
Secondary | The 1 year incidence of thromboembolic events | 1 Year | ||
Secondary | The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE) | 1 Days |
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