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The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.
The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients undergoing catheter ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Procedure | Catheter Ablation of arrhythmias |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Arrhythmia Recurrence | Number and % patients with documented arrhythmias recurrences | 0-10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complications From Catheter Ablation | Number and % of patients with major adverse events as recorded in the medical record | 0-10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing catheter ablation at the OU Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Karen Beckman, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OU Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Catheter Ablation | There is only one arm. Observational study of patients between the ages of 1 and 100 years undergoing catheter ablation of arrhythmias at OUHSC using FDA approved devices. No investigational devices in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Arm | All patients studied |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Patients With Arrhythmia Recurrence | Number and % patients with documented arrhythmias recurrences | Patients who underwent ablation of arrhythmias | Posted | Count of Participants | Participants | 0-10 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 | Observational Arm | Patients undergoing catheter ablation. Catheter Ablation: Catheter Ablation of arrhythmias |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Tamponade | Cardiac disorders | Systematic Assessment | Cardiac Tamponade 3% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IVC thrombus | Vascular disorders | Systematic Assessment | IVC thrombus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Beckman, MD | University of Oklahoma Health Sciences Center | 405-271-9696 | 37536 | karen-beckman@ouhsc.edu |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Patients With Complications From Catheter Ablation | Number and % of patients with major adverse events as recorded in the medical record | Posted | Count of Participants | Participants | 0-10 years |
|
|
|
| 6 |
| 2,420 |
| 72 |
| 2,420 |
| 24 |
| 2,420 |
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| D013514 |
| Surgical Procedures, Operative |