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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_025 |
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| Name | Class |
|---|---|
| Institut für Herzinfarktforschung an der Universität Heidelberg | UNKNOWN |
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This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the characterization of type of Afib, as well as on treatments applied (drugs, devices, interventions and their combinations), and associated complications within 60 days after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) | Baseline (time of admission) | |
| Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission) | Baseline (time of admission) | |
| Clinical Type of Atrial Fibrillation at Baseline (Admission) | Baseline (time of admission) | |
| Treatments Utilized for Participants for Atrial Fibrillation | At time of Treatment (up to 1 day from admission) | |
| Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion | Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered. | At time of treatment (up to 1 day from admission) |
| Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation | up to 60 days from day of treatment (cardioversion) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in a hospital setting in Australia, Brazil, France, Germany, Italy, Netherlands, Poland, UK, Spain, and Sweden from a cross section of different centers including university and non-university hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24556445 | Result | Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25. | |
| 23031215 |
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Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) | All enrolled participants with baseline cardiovascular history data. | Posted | Number | Percentage of Participants | Baseline (time of admission) |
|
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No formal reporting or recording of adverse events was conducted during this observational study.
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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 | All Enrolled Participants | Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Derived |
| Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Total |
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options |
|
|
| Primary | Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission) | All enrolled participants with co-morbity data available. | Posted | Number | Percentage of Participants | Baseline (time of admission) |
|
|
|
| Primary | Clinical Type of Atrial Fibrillation at Baseline (Admission) | All enrolled participants with admission (baseline) atrial fibrillation data available. | Posted | Number | Percentage of Participants | Baseline (time of admission) |
|
|
|
| Primary | Treatments Utilized for Participants for Atrial Fibrillation | All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation. | Posted | Number | Participants | At time of Treatment (up to 1 day from admission) |
|
|
|
| Primary | Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion | Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered. | Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion. | Posted | Number | Percentage of Participants | At time of treatment (up to 1 day from admission) |
|
|
|
| Primary | Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation | All enrolled participants with follow-up data available | Posted | Number | Participants | up to 60 days from day of treatment (cardioversion) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
The Scientific Committee for the study has the authority to make all decisions related to design, conduct, data interpretation and dissemination of study results.
|
| Chronic Renal Failure |
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| Anemia |
|
| Sleep Apnea Syndrome |
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| Haemorrhagic Complication |
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| Title | Measurements |
|---|---|
|
| Persistent |
|
| Permanent |
|
| Unknown |
|
|
| Combined Electrical/Pharmacological Cardioversion |
|
| Rate Control Change |
|
| Catheter Ablation |
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| Surgical Therapy |
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| Implantable Cardiac Defibrillator |
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| Pacemaker |
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| No Treatment |
|
|
|
| Haemorrhagic Stroke |
|
| Peripheral Embolism |
|
| Pulmonary Embolism |
|
| Transient Ischaemic Attack |
|
| Heart Failure |
|
| Major Bleeding |
|
| Minor Bleeding |
|
| Recurrence of Atrial Fibrillation |
|
| Recurrence of Atrial Flutter |
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| Asystole for more than 3 seconds |
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| Symptomatic Ventricular Tachycardia |
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| Ventricular Fibrillation |
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| Sick Sinus syndrome |
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| Torsade de pointes |
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| Syncope |
|
| Endocarditis |
|
| Tamponade |
|
| Bradycardia |
|
| Hypotension |
|
| Other Complication |
|
| Death |
|