Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17)
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|ClinicalTrials.gov Identifier: NCT02426944|
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: NOAC Device: Left atrial appendage closure||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interventional Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-risk Patients With Atrial Fibrillation (PRAGUE-17 Study)|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||May 20, 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: LAAO group
Patients will be treated interventionally by left atrial appendage occlusion (LAAO). LAAO will be done using Amulet or Watchman device.
Device: Left atrial appendage closure
The patients will be treated by interventional closure of the left atrial appendage.
Experimental: NOAC group
Patients will be treated by novel anticoagulants (NOAC).
Medical arm, patients will be treated by NOAC.
- Combined endpoint: stroke OR systemic cardioembolic event OR clinically significant bleeding OR cardiovascular death OR procedure or device-related complications [ Time Frame: 12 months after randomization ]The primary endpoint is the combination of stroke, other systemic cardiovascular event, clinically significant bleeding (i.e. a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding), cardiovascular death or procedure or device-related complications (i.e. a pericardial effusion with a need for drainage, surgical or pericardiocentesis; cardioembolic event during the procedure; significant periprocedural bleeding (such as major vascular bleeding with a need for surgical revision, or blood concentrate transfusion); device embolization, or thrombus of the device with a consequent cardioembolic event).
- Stroke [ Time Frame: 12 months ]The sudden onset of a focal neurologic deficit, from a nontraumatic cause, in a location consistent with the territory of a major cerebral artery and categorized as either an ischemic, hemorrhagic or unspecified
- Systemic cardioembolic event [ Time Frame: 12 months ]An acute vascular occlusion of an extremity or organ, documented by means of imaging (CT angiography, percutaneous interventional angiography), surgery, or autopsy.
- Clinically significant bleeding [ Time Frame: 12 months ]An overt bleeding accompanied by one or more of the following: a decrease in hemoglobin level of 20 g/l or more over a 24-hour period, transfusion of 2 or more units of packed red cells, bleeding at a critical site (intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or retroperitoneal), or fatal bleeding
- Cardiovascular death [ Time Frame: 12 months ]Death from cardiovascular causes
- An procedure or device-related complications [ Time Frame: 12 months ]A pericardial effusion with a need for drainage, surgical or pericardiocentesis, or cardioembolic event during the procedure, or significant periprocedural bleeding (i.e. major vascular bleeding with a need for surgical revision, or blood concentrate transfusion), or device embolization, or (5) thrombus of the device with a consequent cardioembolic event.
- Minor bleeding [ Time Frame: 12 months ]Any bleeding with a need for hospitalization, instrumental procedure or discontinuation of anticoagulation or antithrombotic treatment.
- Economical comparison - all costs associated with the treatment and adverse events [ Time Frame: 12 months ]In the interventional group, costs for device and associated medication (i.e.aspirin and clopidogrel for six weeks). In medical group, all costs for the anticoagulation medication during the whole study period. In both groups, costs associated for hospitalizations due to adverse events will be added.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426944
|Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady||Recruiting|
|Prague, Czechia, 10034|
|Contact: Pavel Osmancik, MD, PhD 00420 ext 721544447 email@example.com|