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The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy with Defibrillation | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia |
| Measure | Description | Time Frame |
|---|---|---|
| Peak VO2 | ||
| NYHA Class | ||
| Six minute walk distance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Higgins, MD | Scripps Memorial Hospital | Principal Investigator |
| Leslie A Saxon, MD | University of California San Francisco Medical Center | Principal Investigator |
| John Boehmer, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Teresa De Marco, MD | University of California San Francisco Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple locations | Saint Paul | Minnesota | 55112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14563591 | Result | Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| D004554 | Electric Countershock |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Quality of life |
| Echocardiographic measures |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |