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Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent instead of warfarin for 3 weeks.
If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transesophageal Echocardiography group | Active Comparator | This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion |
|
| Oral anticoagulant Group | Active Comparator | This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioversion | Procedure | Electrical cardioversion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli | Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion | 2 years |
| Efficacy Clinical End-point | Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli | 2 years |
| Ischemic Stroke/Transient Ischemic Attack | 2 years | |
| Acute Ischemia in MRI | Development of acute silent cerebral ischemia detected by MRI | 1 week |
| Mortality | 2 years | |
| Hemorrhagic Stroke | 2 years | |
| Gastrointestinal Bleeding | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Ozaydin, Professor,MD | Suleyman Demirel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suleyman Demirel University | Isparta | Mediterranean Region | 32260 | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transesophageal Echocardiography Group | This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion Cardioversion: Electrical cardioversion |
| FG001 | Oral Anticoagulant Group | This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. Cardioversion: Electrical cardioversion Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transesophageal Echocardiography Group | This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion Cardioversion: Electrical cardioversion |
| BG001 | Oral Anticoagulant Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | higher values represent worse outcome |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli | Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion | Posted | Count of Participants | Participants | 2 years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transesophageal Echocardiography Group | This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion Cardioversion: Electrical cardioversion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic stroke-transient ischemic attack | Nervous system disorders | Non-systematic Assessment |
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It is a small study. The inclusion criteria were very strict. Patients who required urgent cardioversion, had severe structural heart disease, or conditions that might precipitate atrial fibrillation and those who did not undergo cranial MRI were excluded. Most of the patients had new-onset atrial fibrillation. Therefore the findings of this study cannot be generalized for all atrial fibrillation patients.The evet rates in the both groups were low which decrease the power of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Ozaydin | Akdeniz Sifa Konyaalti Medical Center | 905533354243 | mehmetozaydin@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2024 | Aug 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004554 | Electric Countershock |
| D000925 | Anticoagulants |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
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| Oral Anticoagulant | Drug | warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage |
|
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. Cardioversion: Electrical cardioversion Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Coronary artery disease | Count of Participants | Participants |
|
| Heart rate | higher values represent worse outcome | Mean | Standard Deviation | Beats per minute |
|
| Left atrial diameter | higher values represent worse outcome | Mean | Standard Deviation | mm |
|
| Ejection fraction | higher values represent better outcome | Mean | Standard Deviation | percent |
|
| Type of atrial fibrillation | Count of Participants | Participants |
|
| Duration of atrial fibrillation | higher values represent worse outcome | Median | Full Range | day |
|
| Beta blocker | Count of Participants | Participants |
|
| Calcium channel blocker | Count of Participants | Participants |
|
| Amiodarone | Count of Participants | Participants |
|
| Propafenone | Count of Participants | Participants |
|
| Acetylsalicylic acid | Count of Participants | Participants |
|
| Clopidogrel | Count of Participants | Participants |
|
| Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker | Count of Participants | Participants |
|
| Spironolactone | Count of Participants | Participants |
|
| Congestive heart failure, Hypertension, Age 2, Diabetes, Stroke 2, Vascular, Sex Category Score | Congestive heart failure, Hypertension, Age 2, Diabetes, Stroke 2, Vascular, Sex Category (CHA2DS2-VASc) Score ranges from score 0 (lowest stroke risk) to 9 (highest stroke risk). The total score is provided; subscales are summed to compute a total score; higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
|
| Hypertension,Abnormal liver/renal function, Stroke, Bleeding, LabileINR, Elderly, Drug/alcohol Score | Hypertension,Abnormal liver/renal function, Stroke, Bleeding, LabileINR, Elderly, Drug/alcohol (HAS-BLED) Score ranges from score 0 (lowest bleeding risk) to 9 (highest bleeding risk). Total score is provided; subscales are summed to compute a total score; higher values represent worse outcome | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Efficacy Clinical End-point | Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | Ischemic Stroke/Transient Ischemic Attack | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | Acute Ischemia in MRI | Development of acute silent cerebral ischemia detected by MRI | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Mortality | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | Hemorrhagic Stroke | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Primary | Gastrointestinal Bleeding | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 3 |
| 56 |
| 9 |
| 56 |
| 0 |
| 56 |
| EG001 | Oral Anticoagulation Group | This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. Cardioversion: Electrical cardioversion Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage | 2 | 56 | 10 | 56 | 0 | 56 |
| Hemorrhagic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |