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The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiPole Pacing | Experimental | Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiPole Pacing | Device | CRT non-responders are programmed with MultiPole pacing ON. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature | Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :
| Enrollment to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months. | Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Hospital | Fairhope | Alabama | 36532 | United States | ||
| South Bay Electrophysiology |
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| ID | Title | Description |
|---|---|---|
| FG000 | MultiPole Pacing | Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2019 |
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| Enrollment to 6 Months |
| Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA | Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse). Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit):
| Enrollment to 6 Months |
| CCS Responder Status Utilizing an Expanded Responder Classification | Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :
| Enrollment to 6 Months |
| Inglewood |
| California |
| 90301 |
| United States |
| Eisenhower Desert Cardiology | Rancho Mirage | California | 92270 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Orlando Health Heart Institute | Orlando | Florida | 32806 | United States |
| Florida Hospital Tampa Pepin Heart Institute | Tampa | Florida | 33613 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Parkview Physicians Group - Cardiology | Fort Wayne | Indiana | 46845 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Baptist Health - Lexington | Lexington | Kentucky | 40503 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Northeast Cardiology | Bangor | Maine | 04401 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Southcoast Health | Fall River | Massachusetts | 02720 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Cardiology Associates of North Mississippi | Tupelo | Mississippi | 38801 | United States |
| SSM Health St. Joseph Hospital - St. Charles | Saint Charles | Missouri | 63301 | United States |
| Mercy Clinic Cardiology | Springfield | Missouri | 65804 | United States |
| St. Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Glacier View Medical Research Institute, Cardiology | Kalispell | Montana | 59901 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| New York Presbyterian Queens | Flushing | New York | 11355 | United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Mt. Sinai St. Luke's Hospital | New York | New York | 10025 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Asheville Cardiology Associates | Asheville | North Carolina | 28803 | United States |
| Novant Health Winston-Salem Cardiology | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest Baptist Health Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Medical Center - Fargo | Fargo | North Dakota | 58102 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Temple Heart and Vascular Institute | Philadelphia | Pennsylvania | 19140 | United States |
| Upstate Cardiology | Greenville | South Carolina | 29607 | United States |
| UT Erlanger Cardiology | Chattanooga | Tennessee | 37403 | United States |
| Fort Worth Heart | Fort Worth | Texas | 76104 | United States |
| UT Health Science Center | The Woodlands | Texas | 77380 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | United States |
| UVM Medical | Burlington | Vermont | 05401 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline data collected from all participants enrolled, when available.
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| ID | Title | Description |
|---|---|---|
| BG000 | MultiPole Pacing | Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON. |
| 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, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | in |
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| Weight | Mean | Standard Deviation | Pounds |
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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 | Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature | Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :
| Participants who have completed the MultiPole Pacing (MPP) Sub-study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020. | Posted | Count of Participants | Participants | Enrollment to 6 Months |
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| Secondary | Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months. | Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR). | Evaluable participants for Secondary Endpoint 1 include all participants who have been enrolled into the MPP Sub-Study. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment to 6 Months |
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| Secondary | Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA | Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse). Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit):
| Participants who have completed the MPP Sub-Study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020. | Posted | Count of Participants | Participants | Enrollment to 6 Months |
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| Secondary | CCS Responder Status Utilizing an Expanded Responder Classification | Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders. Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :
| Participants who have completed the MPP Sub-Study 6-Month follow-up visit or experienced a qualifying outcome event as of January 23, 2020. | Posted | Count of Participants | Participants | Enrollment to 6 Months |
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6 months
Sites were required to report any cardiovascular hospitalizations and any other hospitalizations in which cardiovascular symptoms occur on or before the date of the MPP 6-Month follow-up. These hospitalizations were categorized as Heart Failure Hospitalization, Non-Heart Failure Hospitalization, or if applicable, Non-system related/non-protocol defined. Extracardiac stimulation was assessed/categorized however other specific adverse event terms were not assessed.
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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 | MultiPole Pacing | Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up. MultiPole Pacing: CRT non-responders are programmed with MultiPole pacing ON. | 3 | 53 | 5 | 53 | 6 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure Hospitalization | Cardiac disorders | Systematic Assessment |
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| Non-Heart failure Hospitalization | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-system related/ Non Protocol-defined | Cardiac disorders | Systematic Assessment |
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| Extracardiac stimulation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Engineer Manager | BIOTRONIK | 800-547-0394 | crystal.miller@biotronik.com |
| Jan 22, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
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