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for administrative reasons (no safety concerns), no analysis completed
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to compare Dual LV (left ventricular) pacing to standard single LV pacing (BiV pacing) to see if Dual LV pacing:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Site LV Pacing | Active Comparator | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. |
|
| BiV Pacing | Active Comparator | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Site LV Pacing | Device | Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End Systolic Volume (LVESV) | The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient. | At 6 months to one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran K Niazi, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Cardiovascular Services | Lake Geneva | Wisconsin | 53147 | United States | ||
| Aurora Cardiovascular Services |
Subjects are consented and randomized before the pacing prodecure. They may have been excluded (considered screen fails) if they end up not having the procedure or being identified as inappropriate once the procedure began. 50 Consented and 41 Randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. |
| FG001 | BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 3 Months |
| |||||||||||||
| 3 to 6 Months |
| |||||||||||||
| 6 Months to Study Completion |
|
Includes both randomized groups, Group A: Randomized to Dual LV pacing for three months then crossed over to Standard BiV pacing for three months, then programmed at the physician discretion. Group B: Randomized to Standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed to physician discretion.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study. |
| 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 | Change in Left Ventricular End Systolic Volume (LVESV) | The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient. | Analysis population was based on the two randomized groups per the protocol. | Posted | Mean | Standard Deviation | ml | At 6 months to one year |
|
1 year
Adverse Events were collected per intervention.
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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 | Dual Site LV Pacing | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Vascular disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by spontaneous loss of consciousness caused by insufficient blood supply to the brain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diaphragmatic Stimulation | General disorders | CTCAE v4.0.3 | Non-systematic Assessment | Simulation of the phrenic nerve or diaphragm by a pacing output pulse, causing a hiccough-like reaction. |
Study terminated early form administrative reasons (no safety concerns), no analysis was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Imran K. Niazi, MD | Aurora Health Care | 414-645-6070 | imran.niazi@aurora.org |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| BiV Pacing | Device | Dual Site LV Pacing vs. BiV Pacing for a total of six months which includes two three crossover periods. |
|
| Milwaukee |
| Wisconsin |
| 53215 |
| United States |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 41 |
| 10 |
| 41 |
| EG001 | BiV Pacing | Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing. Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study. | 3 | 41 | 3 | 41 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0.3 | Non-systematic Assessment | disorder characterized by an uncomfortable sensation of difficulty breathing. |
|
| Heart failure | Cardiac disorders | CTCAE v4.0.3 | Non-systematic Assessment | (exacerbation of existing condition) A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure. |
|
| Death | General disorders | CTCAE v4.0.3 | Non-systematic Assessment | (not related to investigation) |
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| Multi-organ failure | General disorders | CTCAE v4.0.3 | Non-systematic Assessment | (not related to investigation) A disorder characterized by progressive deterioration of the lungs, liver, kidney and clotting mechanisms. |
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| Sepsis | Blood and lymphatic system disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock. |
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| Fall | General disorders | CTCAE v4.0.3 | Non-systematic Assessment | A finding of sudden movement downward, usually resulting in injury. |
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| Chest pain - cardiac | Cardiac disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by pathological irregularities in the cardiac conduction system. |
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| Hyperkalemia | Renal and urinary disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by laboratory test results that indicate an elevation in the concentration of potassium in the blood; associated with kidney failure or sometimes with the use of diuretic drugs. |
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| Vomiting | Gastrointestinal disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth. |
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| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE v4.0.3 | Non-systematic Assessment | GI bleed, non specific |
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| Stomach pain | Gastrointestinal disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by a sensation of marked discomfort in the stomach. |
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| Rectal fistula | Gastrointestinal disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by an abnormal communication between the rectum and another organ or anatomic site. |
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| ICD shock | Cardiac disorders | CTCAE v4.0.3 | Non-systematic Assessment |
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| Lead dislodgement | Cardiac disorders | CTCAE v4.0.3 | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood. |
|
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| Fatigue | General disorders | CTCAE v4.0.3 | Non-systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
|
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