Atrial FibrillationNCT03795883
The Thrombotic Potential of Heart Chambers in the Presence or Absence of Atrial Fibrillation.
An observational study of Atrial Fibrillation and Thrombosis Cardiac, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombosis Cardiac, Left Atrial Thrombosis
- How many people
- 47 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2019to 9 Mar 2022
- Phase
- Observational
- 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
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.
Who may be able to join
- Age above 18
- Pulmonary vein ablation, SVT ablation or mitral clip.
- Informed consent
Who cannot join
- Left atrial thrombus
- Pregnancy
- Active malignancy
- Thrombophilia
- Anticoagulants 24 hours before procedure
- Active infectious disease
- Chronic kidney disease (eGFR<30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.
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.
- Keywords
- Thrombin generation, Calibrated automated thrombogram, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)
ETP (endogenous thrombotic potential) nM*min
Measured: 1 Day
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)
Peak height nM
Measured: 1 Day
Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)
Lag time in minutes
Measured: 1 Day
Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)
Time to peak in minutes
Measured: 1 Day
Secondary outcomes (2)
The 1 year incidence of thromboembolic events
Measured: 1 Year
The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)
Measured: 1 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2021
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adi Elias MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795883
- Sponsor's protocol ID
- RMB CTIL-0216-18
- Status last verified
- Mar 2022
- First submitted
- 30 Dec 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37063762
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thrombotic Potential (Thrombin Generation) of Left Atrium and Other Heart Chambers in Atrial Fibrillation Patients Compared to Patients Without Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT03795883
- Acronym / sponsor ID
- RMB CTIL-0216-18
- Keywords
- Thrombin generation, Calibrated automated thrombogram, Atrial fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age above 18
- Pulmonary vein ablation, SVT ablation or mitral clip.
- Informed consent
Key exclusion criteria (7 listed)
- Left atrial thrombus
- Pregnancy
- Active malignancy
- Thrombophilia
- Anticoagulants 24 hours before procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ETP of various heart chambers measured by the calibrated automated thrombogram (CAT)
Time frame: 1 Day
ETP (endogenous thrombotic potential) nM*min
Peak height of various heart chambers measured by the calibrated automated thrombogram (CAT)
Time frame: 1 Day
Peak height nM
Lag time of various heart chambers measured by the calibrated automated thrombogram (CAT)
Time frame: 1 Day
Lag time in minutes
Time to peak of various heart chambers measured by the calibrated automated thrombogram (CAT)
Time frame: 1 Day
Time to peak in minutes
2 secondary outcomes
The 1 year incidence of thromboembolic events
Time frame: 1 Year
The number of participants with spontaneous echocardiographic contrast demonstrated in trans-esophageal echocardiogram (TEE)
Time frame: 1 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Derived from this study: PubMed 37063762Elias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thrombosis Cardiac, run by Rambam Health Care Campus at 1 site 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 3 inclusion and 7 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
ETP of various heart chambers measured by the calibrated automated thrombogram (CAT) (time frame: 1 Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795883, which also lists 1 linked publication.
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 10 Mar 2022.