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This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.
All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened" or "Unchanged" using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with "equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-point pacing arm | Experimental | MultiPoint Pacing |
|
| Biventricular arm | Active Comparator | Traditional Biventricular Pacing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiPoint Pacing | Device | Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion | A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint. | Implant to 9 months |
| Percentage of Non-responders With MPP Compared to Biventricular Pacing | The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below:
For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders. | 3 months to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gery Tomassoni, MD | Central Baptist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC. | Huntsville | Alabama | 35801 | United States | ||
| Banner Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028082 | Derived | Varma N, Baker J 2nd, Tomassoni G, Love CJ, Martin D, Sheppard R, Niazi I, Cranke G, Lee K, Corbisiero R. Left Ventricular Enlargement, Cardiac Resynchronization Therapy Efficacy, and Impact of MultiPoint Pacing. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008680. doi: 10.1161/CIRCEP.120.008680. Epub 2020 Oct 7. | |
| 29759832 | Derived |
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The study results will be presented at HRS Late-Breaking Clincial Trials Session in May, 2016
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455 out of 469 subjects with an attempted implant (97% success rate) received Quadripolar BiV pacing between implant and 3 months. At 3 months, responder status was assessed per Clincial Composite Score and 1:1 randomziation was stratified by responder status. 381 patients were randomized to either BiV (n = 180) or MPP (n = 201) at 3 months.
The study enrolled 506 subjects at 49 investigational centers located in the U.S. A patient was considered enrolled upon signing informed consent. The first subject was enrolled on April 25, 2013. The study was double-blinded (the study subjects and the authorized personnel conducting the NYHA Class and Patient Global assessments were blinded).
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-point Pacing Arm | Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study. |
| FG001 | Biventricular Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Traditional Biventricular Pacing | Device | Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available. |
|
| Mesa |
| Arizona |
| 85027 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Glendale Memorial Hospital and Medical Center | Glendale | California | 91206 | United States |
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| Premier Cardiology, Inc | Newport Beach | California | 92663 | United States |
| Regional Cardiology Associates | Sacramento | California | 95819 | United States |
| Sutter Memorial Hospital | Sacramento | California | 95819 | United States |
| Colorado Heart & Vascular, P.C. | Lakewood | Colorado | 80228 | United States |
| Cardiology Associates of Fairfield County, PC | Norwalk | Connecticut | 06851 | United States |
| Christiana Hospital | Newark | Delaware | 19718 | United States |
| Bay Area Cardiology Associates PA | Brandon | Florida | 33511 | United States |
| Watson Clinic Center | Lakeland | Florida | 33805 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| St. Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| HeartCare Midwest | Peoria | Illinois | 61614 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | United States |
| Thoracic Cardio Healthcare Foundation | Lansing | Michigan | 48910 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Novant Health Heart and Vascular Research Institute | Charlotte | North Carolina | 28204 | United States |
| Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina | 27157 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43124 | United States |
| The Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| WellSpan Health | York | Pennsylvania | 17403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| Vanderbilt Heart and Vascular Institute | Nashville | Tennessee | 37232 | United States |
| Cardiology Center of Amarillo, L.L.P | Amarillo | Texas | 79106 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| South Texas Cardiovascular Consultants | San Antonio | Texas | 78201 | United States |
| Cardiovascular Associates, LTD | Virginia Beach | Virginia | 23454 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Niazi I, Baker J 2nd, Corbisiero R, Love C, Martin D, Sheppard R, Worley SJ, Varma N, Lee K, Tomassoni G; MPP Investigators. Safety and Efficacy of Multipoint Pacing in Cardiac Resynchronization Therapy: The MultiPoint Pacing Trial. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1510-1518. doi: 10.1016/j.jacep.2017.06.022. Epub 2017 Sep 27. |
Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available. |
| Per Protocol Population at 9 Months |
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| COMPLETED |
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| NOT COMPLETED |
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A total of 381 subjects were randomized at 3 months, of whom 180 were in the BiV arm and 201 were in the MPP arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | MultiPoint Pacing Arm | Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study. |
| BG001 | Biventricular Arm | Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Ethnicity | Number | participants |
| ||||||||||||||||
| RACE | Number | participants |
| ||||||||||||||||
| QRS Duration | Mean | Standard Deviation | ms |
| |||||||||||||||
| QRS Morphology | Number | participants |
| ||||||||||||||||
| Cardiomyopathy Etiology | Number | 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 | Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion | A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint. | Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication). | Posted | Number | 95% Confidence Interval | Event-Free Probability | Implant to 9 months |
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| Primary | Percentage of Non-responders With MPP Compared to Biventricular Pacing | The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below:
For patients who were responders at the 3-month visit, those who were "Improved" and "Unchanged" between 3 and 9 months were classified as responders, whereas those who were "Worsened" were grouped together as non-responders. | Posted | Number | percentage of patients | 3 months to 9 months |
|
3-month randomization to 9 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 | MultiPoint Pacing Arm | Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study. | 4 | 201 | 40 | 201 | ||
| EG001 | Biventricular Arm | Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available. | 3 | 180 | 5 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LV Lead Dislodgement or Migration | Cardiac disorders | Systematic Assessment |
| ||
| RA/RV Lead Dislodgement or Migration | Cardiac disorders | Systematic Assessment |
| ||
| Pulse Generator Erosion/Extrusion | Cardiac disorders | Systematic Assessment |
| ||
| Generator Malfunction | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LV Lead Elevated Pacing Thresholds | Cardiac disorders | Systematic Assessment |
| ||
| LV Lead Loss of Capture | Cardiac disorders | Systematic Assessment |
| ||
| Phrenic Nerve/Diaphragmatic Stimulation Related to LV Lead | Cardiac disorders | Systematic Assessment |
| ||
| Rise in Threshold And Exit Block Related to LV Lead | Cardiac disorders | Systematic Assessment |
| ||
| RA/RV Lead Elevated Pacing Thresholds | Cardiac disorders | Systematic Assessment |
| ||
| RA/RV Lead Loss of Capture | Cardiac disorders | Systematic Assessment |
| ||
| RA/RV Lead Oversensing | Cardiac disorders | Systematic Assessment |
| ||
| Artifact Observed on Atrial Channel | Cardiac disorders | Systematic Assessment |
| ||
| Discomfort Around Device | Cardiac disorders | Systematic Assessment |
| ||
| Intolerance to MPP Pacing | Cardiac disorders | Systematic Assessment |
| ||
| Pulse Generator Oversensing | Cardiac disorders | Systematic Assessment |
| ||
| Pacemaker Mediated Tachycardia (PMT) | Cardiac disorders | Systematic Assessment |
| ||
| Intolerance to BiV Pacing | Cardiac disorders | Systematic Assessment |
| ||
| Thrombo-Embolic Event | Cardiac disorders | Systematic Assessment |
| ||
| Erythema to Lateral Aspect of Incision Site | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Studies | St. Jude Medical | 972-309-8000 | 8087 | ccohorn@sjm.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Non-Hispanic or Latino |
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| Black or African American |
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| Asian |
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| Other |
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| Right Bundle Branch Block (RBBB) |
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| Interventricular Conduction Delay (IVCD) |
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| Unknown |
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| Non-ischemic |
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| None |
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