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The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT-D and LV lead | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D and LV lead (Quartet™ lead and Promote Q® device system) | Device | Promote Q CRT-D and Quartet LV lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Left Ventricular Lead-Related Complications Through 3 Months | The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months. | 3 months |
| Freedom From System-related Complications Through 3 Months | The co-primary safety endpoint for this study is freedom from system-related complications through 3 months. | 3 Months |
| The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. | The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil). | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gery Tomassoni, MD | Central Baptist Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Baptist Health Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23339555 | Result | Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CRT-D and LV Lead | CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Glendale Memorial Medical Center | Glendale | California | 91204 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| ACS Research Group | Mountain View | California | 94040 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| Scripps Green Hospital | San Diego | California | 92037 | United States |
| Orlando Heart Center | Orlando | Florida | 32806 | United States |
| The Heart and Vascular Institute of Florida - S. Pinellas | St. Petersburg | Florida | 33705 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Midwest Heart Foundation | Lombard | Illinois | 60148 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Lahey Clinical Medical Center | Burlington | Massachusetts | 01805 | United States |
| Thoracic Cardiovascular Healthcare Foundation | Lansing | Michigan | 48910 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| EMH Regional Medical Center | Elyria | Ohio | 44035 | United States |
| Lancaster Heart Foundation | Lancaster | Pennsylvania | 17602 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| Arrhythmia Center for Southern Wisconsin | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CRT-D and LV Lead | CRT-D and LV lead (Quartet™ lead and Promote Q® device system): Promote Q CRT-D and Quartet LV lead |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||
| New York Heart Association Class | The New York Heart Association (NYHA) classification system is the most commonly used classification system for heart failure. Class I (least severe): No symptoms and no limitations on ordinary physical activity; Class II: Mild symptoms and slight limitations on ordinary physical activity; Class III: Marked limitation on activity due to symptoms; Class IV (most severe): Severe limitations and even symptoms at rest. | Number | participants |
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| 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 | Freedom From Left Ventricular Lead-Related Complications Through 3 Months | The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months. | Patients implanted with a Promote Q CRT-D device and Quartet LV lead. | Posted | Number | 97.5% Confidence Interval | percentage probability | 3 months |
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| Primary | Freedom From System-related Complications Through 3 Months | The co-primary safety endpoint for this study is freedom from system-related complications through 3 months. | Participants implanted with a Promote Q CRT-D device and Quartet LV lead. | Posted | Number | 97.5% Confidence Interval | percentage probability | 3 Months |
|
| ||||||||||||||||||||||||||
| Primary | The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. | The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil). | Posted | Number | 97.5% Confidence Interval | percentage of participants | 3 Months |
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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 | CRT-D and LV Lead | CRT-D and LV Lead | 0 | 178 | 76 | 178 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications | Cardiac disorders |
| |||
| Observations | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn: Director, Clinical Study Management | St. Jude Medical | 972 309 8087 | ccohorn@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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