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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL080152-01A2 | U.S. NIH Grant/Contract | View source |
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Slow accrual and anticipated loss of funding
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.
This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiVP Pacing | Experimental | BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output. |
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| AAI Pacing | Active Comparator | Traditional atrial (AAI) pacing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiVP | Device | Biventricular pacing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output | The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately. | 13 minutes of testing; performed before CPB for allograft receipt |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Latency | 13 minutes of testing; performed before CPB for allograft receipt | |
| Interatrial Delay (Between Right Atrium and Left Atrium) | Results could not be analyzed due to poor enrollment and lack of data. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry M Spotnitz, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medial Center | New York | New York | 10032 | United States |
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Data could not be analyzed due to poor enrollment and lack of data. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects in the Study | This includes all subjects in the study. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects in the Study | This includes all subjects in the study. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Cardiac Output | The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately. | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
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Adverse Events are not available due to poor enrollment and lack of data.
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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 | All Subjects in the Study | This includes all subjects in the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henry M. Spotnitz, MD | Columbia University | (212) 305-6191 | hms2@columbia.edu |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| AAI Pacing | Device | Atrial pacing |
|
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| 13 minutes of testing; performed before CPB for allograft receipt |
| Peak LV dP/dt | 13 minutes of testing; performed before CPB for allograft receipt |
| Peak RV dP/dt | 13 minutes of testing; performed before CPB for allograft receipt |
| Interventricular Synchrony | 13 minutes of testing; performed before CPB for allograft receipt |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Atrial Latency | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
|
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| Secondary | Interatrial Delay (Between Right Atrium and Left Atrium) | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
|
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| Secondary | Peak LV dP/dt | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
|
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| Secondary | Peak RV dP/dt | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
|
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| Secondary | Interventricular Synchrony | Results could not be analyzed due to poor enrollment and lack of data. | Posted | 13 minutes of testing; performed before CPB for allograft receipt |
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| 0 |
| 12 |
| 0 |
| 12 |
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| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |