- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499612
Influence of Cardiac Implantable Electronic Devices on the Hemostatic System
Assessment of the Hemostatic System, Thromboembolic Complications and Cardiovascular Events in Patients With Cardiovascular Implantable Electronic Devices
The hemostasis system is one of the many biological systems of the human body, designed to preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal balance between its coagulant and anticoagulant components never occurs. In various diseases and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts towards hypercoagulability lead to the development of hemorrhagic complications, opposite shifts lead to the development of thrombotic complications.
Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today doctors meet with them every day. Its more than 1.5 million CIED's implanted every year.
Before surgery these patients are standard cardiology department patients with chronic heart failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease, hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases and conditions. CHF is the most common, severe and unfavorable prognostic complication of these diseases. With CHF, the balance of the hemostasis system shifts towards hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis, pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and other complications.
After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition in the early postoperative period. In the long-term period, pacing, on the contrary, may contribute to the progression of CHF. The wrong choice of pacing mode or the place of electrode implantation can lead to desynchronization of the heart chambers, myocardial remodeling and left ventricular dysfunction.
Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the vessel wall during surgery, further placement of the CIED leads in the vessels, and perioperative stress can lead to even greater shifts towards hypercoagulation.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Vladislav O. Povarov, MD, PhD
- Phone Number: +7-915-602-7478
- Email: povarov.vladislav@mail.ru
Study Contact Backup
- Name: Igor A. Suchkov, MD, DSc
- Phone Number: +7-903-836-2417
- Email: suchkov_med@mail.ru
Study Locations
-
-
Ryazan
-
Ryazan', Ryazan, Russian Federation
- Ryazan State Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- for group A1-3: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction as indications for cardiac implantable electronic device implantation;
- for group B: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction and cardiac implantable electronic device implanted 6-12 years ago;
- for group C: atrioventricular block/sick sinus syndrome/atrial fibrillation with impaired conduction without indications for cardiac implantable electronic device implantation.
Exclusion Criteria:
- active cancer or a remission period of less than 5 years;
- decompensated somatic pathology;
- pregnancy or breastfeeding in women.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group "Single-chamber CIED" (A1)
50 patients with permanent atrial fibrillation and indications for cardiac implantable electronic device implantation (single-chamber system).
|
Patients who have indications will receive cardiac implantable electronic device implantation.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Patients will undergo an ultrasound examination of the heart.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
|
Group "Dual-chamber CIED" (A2)
50 patients with atrioventricular block/sick sinus syndrome and indications for cardiac implantable electronic device implantation (dual-chamber system).
|
Patients who have indications will receive cardiac implantable electronic device implantation.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Patients will undergo an ultrasound examination of the heart.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
|
Group "Dual-chamber CIED + Atrial fibrillation" (A3)
50 patients with atrioventricular block/sick sinus syndrome, paroxysmal or persistent atrial fibrillation and indications for cardiac implantable electronic device implantation (dual-chamber system).
|
Patients who have indications will receive cardiac implantable electronic device implantation.
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Patients will undergo an ultrasound examination of the heart.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
|
Group "CIED Replace" (B)
50 patients with cardiac implantable electronic device implantation 6-12 years ago (single- or dual-chamber system).
|
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Patients will undergo an ultrasound examination of the heart.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
Patients who have indications will receive cardiac implantable electronic device replace.
|
Group "Conservative" (C)
50 patients with atrioventricular block/sick sinus syndrome/atrial fibrillation and without indications for cardiac implantable electronic device implantation (conservative group).
|
Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
Patients will undergo an ultrasound examination of the heart.
Patients will be taken venous blood to determine the studied markers of hemostasis system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of thromboembolism: venous thrombosis, pulmonary embolism, arterial thrombosis, arterial thromboembolism, transient ischemic attack, stroke.
Time Frame: Up to 2 years after enrollment (according to the study design).
|
Development of thromboembolic complications after the cardiac implantable electronic device implantation/replace or thromboembolism in conservative group patients during observation period.
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Up to 2 years after enrollment (according to the study design).
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Development of cardiovascular event: myocardial infarction, acute coronary syndrome, atrial fibrillation, decompensation of chronic heart failure.
Time Frame: Up to 2 years after enrollment (according to the study design).
|
Development of cardiovascular events after the cardiac implantable electronic device implantation/replace or in conservative group patients during observation period.
|
Up to 2 years after enrollment (according to the study design).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemostasis system markers deviations.
Time Frame: Up to 2 years after enrollment (according to the study design).
|
Deviation of investigated markers of the hemostasis system from normal values.
|
Up to 2 years after enrollment (according to the study design).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Igor A. Suchkov, MD, DSc, Ryazan State Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/290120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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