Trial · NCT02100228
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Acute Stroke Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma). |
| Primary | Number of Participants With Systemic Embolism Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. |
| Primary | Number of Participants With Major Bleeding Event | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal. |
| Primary | Number of Participants With Clinically Relevant Non-Major Bleeding Events | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life. |
| Primary | Number of Participants With All Cause Death | Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame) | |
| Secondary | Time to First Attempt of Cardioversion | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure. |
| Secondary | Number of Participants With Different Type of Cardioversion Events | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock. |
| Secondary | Number of Cardioversion Attempt of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission. |
| Secondary | Number of Participants With Their Rhythm Status | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute). |
| Secondary | Duration of Hospital Stay of Participants | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion. |
| Secondary | Number of Participants Who Used Image Guidance Approach | Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days) | An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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