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Investigator left Institution.
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter Ablation | Active Comparator | Catheter ablation procedure of atrial and/or ventricular arrhythmias. |
|
| Medical Therapy | Active Comparator | Medical management using antiarrhythmic drugs per standard of care of treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Procedure | Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ejection Fraction (EF) | Change in Ejection Fraction (EF) | 90 Days |
| Bi-ventricular Pacing Improvement | data not analyzed | 90 Days |
| Cardiovascular Mortality | data not analyzed | 365Days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | data was not analyzed | 365 Days |
| Hospital Admissions for Heart Failure Exacerbation | data not analyzed | 365 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | Kansas City Heart Rhythm Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Therapy | The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician. |
| FG001 | Ablation Arm | Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
data not collected to be analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Catheter Ablation | Catheter ablation procedure of atrial and/or ventricular arrhythmias. Catheter Ablation: Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists. |
| BG001 | Medical Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Change in Ejection Fraction (EF) | Change in Ejection Fraction (EF) | data not analyzed | Posted | 90 Days |
|
Adverse Events were not monitored/assessed.
Adverse Events were not monitored/assessed. No data collected - enrolled two patients and that is all. Study was cancelled.
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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 | Medical Therapy | The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dhanunjaya Lakkireddy | Kansas City Heart Rhythm Institute | 913-449-1297 | dhanunjaya.lakkireddy@hcahealthcare.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 | Mar 29, 2017 | Feb 18, 2021 | Prot_SAP_001.pdf |
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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 |
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Anti-Arrhythmics | Drug | Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician. |
|
| New York Heart Association (NYHA) Class Change | 30 Days |
| Change in 6 Minute Walk Test | data not analyzed | 30 Days |
| Change in Quality of Life - SF-36 | data not analyzed | 30 Days |
| Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) | data not analyzed | 30 Days |
Medical management using antiarrhythmic drugs per standard of care of treating physician. Anti-Arrhythmics: Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician. |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment |
|
| Units | Counts |
|---|---|
| Participants |
|
| Primary | Bi-ventricular Pacing Improvement | data not analyzed | data not analyzed | Posted | 90 Days |
|
|
| Primary | Cardiovascular Mortality | data not analyzed | data not analyzed | Posted | 365Days |
|
|
| Secondary | All-cause Mortality | data was not analyzed | data not analyzed | Posted | 365 Days |
|
|
| Secondary | Hospital Admissions for Heart Failure Exacerbation | data not analyzed | data not analyzed | Posted | 365 Days |
|
|
| Secondary | New York Heart Association (NYHA) Class Change | data not analyzed | Posted | 30 Days |
|
|
| Secondary | Change in 6 Minute Walk Test | data not analyzed | data not analyzed | Posted | 30 Days |
|
|
| Secondary | Change in Quality of Life - SF-36 | data not analyzed | data not analyzed | Posted | 30 Days |
|
|
| Secondary | Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ) | data not analyzed | data not analyzed | Posted | 30 Days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ablation Arm | Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013514 |
| Surgical Procedures, Operative |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |