MPP-PMS: MultiPoint Pacing™ Post Market Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02832622
• Collaborator: (none)
• Enrollment: 2,169
• Locations: 128
• Duration (Months): 36.4
• Patients Per Site: 16.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: MPP; Device: BiV/MPP

Detailed Description

Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.

Study Design

• Study Type: Observational
• Actual Enrollment: 2169 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MultiPoint Pacing™ Post Market Study
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Jul 15, 2019
• Actual Study Completion Date: Jul 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
MPP Programming This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.	Device: MPP; MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously); Device: BiV/MPP; MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)

Outcome Measures

Primary Outcome Measures

1. Number of CRT Responders as Measured by the Clinical Composite Score (CCS) [One year]

   The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.

Other Outcome Measures

1. Change in Quality of Life [baseline and one year]

   The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.

2. Duration of MPP Programming in Months [One year]

   The duration of MPP programming in months in the treatment groups.

3. Number of MPP Programming Optimizations Per Subject [One year]

   The number of MPP programming optimizations per subject

4. Number of Subjects With Heart Failure Hospitalization [One year]

   HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure: Hospitalization for HF ≥ 24 hours Clinic or hospital visit for HF<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators

5. Number of Subjects With Cardiovascular Hospitalization [One year]

   Number of subjects with cardiovascular hospitalization as reported by the sites

6. Number of Subjects With Heart Failure 30-day Hospitalization [30 days]

   Number of subjects with heart failure 30-day hospitalization as reported by the sites

7. Number of Deaths [One year]

   Overall mortality rate for all subjects who started the trial is summarized.

8. Change in Left Ventricular Ejection Fraction [baseline and one year]

   Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)

9. Change in Left Ventricular End Systolic Volume [baseline and one year]

   Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement

• Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

• Are expected to receive a heart transplant during the duration of the study

• Have an epicardial ventricular lead system (Active or Inactive)

• Are less than 18 years of age

• Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm

• Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35249
2	Heart Center Research, LLC.	Huntsville	Alabama	United States	35801
3	Integrated Medical Services	Avondale	Arizona	United States	85392
4	Cardiovascular Consultants Ltd	Glendale	Arizona	United States	85306
5	Arizona Arrhythmia Research Center	Phoenix	Arizona	United States	85013
6	Phoenix Cardiovascular Research Group	Phoenix	Arizona	United States	85018
7	John C. Lincoln North Mountain Hospital	Phoenix	Arizona	United States	85020
8	Arizona Arrhythmia Consultants	Scottsdale	Arizona	United States	85251
9	Comprehensive Cardiovascular Specialists	Alhambra	California	United States	91801
10	USC University Hospital	Los Angeles	California	United States	90033
11	Jeffrey Goodman	Los Angeles	California	United States	90048
12	Premier Cardiology, Inc	Newport Beach	California	United States	92663
13	Desert Heart Rhythm Consultants	Palm Springs	California	United States	92262
14	Chaparral Medical Group	Pomona	California	United States	91767
15	Cardiac Rhythm Specialists, Inc.	Reseda	California	United States	91335
16	San Diego Cardiac Center	San Diego	California	United States	92123
17	COR Healthcare Medical Associates	Torrance	California	United States	90505
18	Aurora Denver Cardiology Associates, P.C.	Aurora	Colorado	United States	80012
19	Cardiology Associates of Fairfield County, PC	Norwalk	Connecticut	United States	06851
20	Cardiac Arrhythmia Services	Boca Raton	Florida	United States	33422
21	Yoel R. Vivas, MD	Delray Beach	Florida	United States	33484
22	Heart Rhythm Solutions	Hollywood	Florida	United States	33021
23	Citrus Cardiology Consultants, PA	Inverness	Florida	United States	34452
24	St. Vincent's Medical Center	Jacksonville	Florida	United States	32204
25	Naushad Shaik, MD	Kissimmee	Florida	United States	34741
26	Jorge Diaz, M.D., P.A.	Lake Mary	Florida	United States	32746
27	Central Florida Medical Research	New Smyrna Beach	Florida	United States	32168
28	Usman R. Siddiqui, MD	Orlando	Florida	United States	32837
29	Sacred Heart Hospital	Pensacola	Florida	United States	32504
30	Brevard Cardiovascular Research Associates, Inc.	Rockledge	Florida	United States	32955
31	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
32	VA Medical Center - Tampa	Tampa	Florida	United States	33612
33	Piedmont Athens Regional Medical Center	Athens	Georgia	United States	30606
34	Emory University Hospital	Atlanta	Georgia	United States	30342
35	Coliseum Medical Centers	Macon	Georgia	United States	31201
36	Redmond Regional Medical Center	Rome	Georgia	United States	30165
37	Illinois Heart and Vascular - Hinsdale	Hinsdale	Illinois	United States	60521
38	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
39	Reid Health	Richmond	Indiana	United States	47374
40	Healient Physician Group	Leawood	Kansas	United States	66211
41	Central Baptist Hospital	Lexington	Kentucky	United States	40503
42	Jewish Hospital	Louisville	Kentucky	United States	40202
43	One Health Cardiology	Owensboro	Kentucky	United States	42304
44	Gregory C. Sampognaro Interventional Cardiology	Monroe	Louisiana	United States	71201
45	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
46	Advanced Cardiovascular Specialists	Shreveport	Louisiana	United States	71103
47	LSU Health Sciences Center	Shreveport	Louisiana	United States	71130
48	Eastern Maine Medical Center	Bangor	Maine	United States	04401
49	MedStar Health Research Institute	Hyattsville	Maryland	United States	20782
50	Boston Medical Center	Boston	Massachusetts	United States	02118
51	Charlton Memorial Hospital	Fall River	Massachusetts	United States	02720
52	Trinity Health-Michigan d/b/a Michigan Heart	Ann Arbor	Michigan	United States	48106
53	Michigan Electrophysiology Specialists	Flushing	Michigan	United States	48433
54	Sparrow Clinical Research Institute	Lansing	Michigan	United States	48912
55	MidMichigan Medical Center-Midland	Midland	Michigan	United States	48670
56	Michigan Cardiovascular Institute	Saginaw	Michigan	United States	48601
57	Providence Hospital	Southfield	Michigan	United States	48075
58	Munson Medical Center	Traverse City	Michigan	United States	49684
59	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
60	St. Luke's Hospital	Kansas City	Missouri	United States	64111
61	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
62	St. Louis Heart and Vascular PC	Saint Louis	Missouri	United States	63136
63	Kearney Regional Medical Center	Kearney	Nebraska	United States	68845
64	BryanLGH Medical Center East	Lincoln	Nebraska	United States	68506-1299
65	HealthCare Partners Cardiology	Las Vegas	Nevada	United States	89169
66	Catholic Medical Center	Manchester	New Hampshire	United States	03102
67	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
68	Atlantic Health System - Morristown Memorial Hospital	Morristown	New Jersey	United States	07962
69	Jersey Shore University Medical Center	Neptune	New Jersey	United States	08015
70	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
71	Presbyterian Heart Group	Albuquerque	New Mexico	United States	87106
72	St. Peter's Health Partners Medical Associates, PC	Albany	New York	United States	12205
73	Trinity Medical WNY, PC	Buffalo	New York	United States	14215
74	Novant Health Heart and Vascular Research Institute	Charlotte	North Carolina	United States	28204
75	VA Medical Center Durham	Durham	North Carolina	United States	27705
76	Highpoint Regional Hospital	High Point	North Carolina	United States	27262
77	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
78	University Hospitals Elyria Medical Center	Elyria	Ohio	United States	44035
79	Middletown Cardiovascular Associates	Middletown	Ohio	United States	45044
80	Samaritan Heart & Vascular Institute - Cardiology Dept.	Corvallis	Oregon	United States	97330
81	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
82	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-2150
83	Presbyterian Medical Center (PA)	Philadelphia	Pennsylvania	United States	19104
84	Scranton Cardiovascular Physicians	Scranton	Pennsylvania	United States	18510
85	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania	United States	19067
86	Pee Dee Cardiology Associates, PA	Florence	South Carolina	United States	29506
87	St. Francis Hospital	Greenville	South Carolina	United States	29601
88	Lexington Cardiology	Lexington	South Carolina	United States	29204
89	Mountain States Medical Group Cardiology	Johnson City	Tennessee	United States	37601
90	Cardiovascular Associates, PC (Wellmont Holston Valley M C)	Kingsport	Tennessee	United States	37660
91	Methodist University Hospital	Memphis	Tennessee	United States	38104
92	Austin Heart	Austin	Texas	United States	78756
93	HeartPlace	Bedford	Texas	United States	76021
94	Fort Worth Heart	Fort Worth	Texas	United States	76104
95	Houston Cardiovascular Associates	Houston	Texas	United States	77030
96	Memorial Hermann Hospital	Houston	Texas	United States	77030
97	South Texas Cardiovascular Consultants	San Antonio	Texas	United States	78201
98	Cardiology Clinic Of San Antonio Pa	San Antonio	Texas	United States	78229
99	Wichita Falls Heart Clinic	Wichita Falls	Texas	United States	76301
100	McKay-Dee Heart Services	Ogden	Utah	United States	84403
101	University of Utah Hospital	Salt Lake City	Utah	United States	84132
102	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
103	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
104	Virginia Heart - The Cardiovascular Group, P.C.	Falls Church	Virginia	United States	22042
105	Bayview Physicians Services, PC	Virginia Beach	Virginia	United States	23454
106	Kootenai Heart Clinics	Spokane	Washington	United States	92204
107	St. Mary's Hospital	Huntington	West Virginia	United States	25702
108	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
109	Aspirus Wausau Hospital	Wausau	Wisconsin	United States	54401
110	Wheaton Franciscan Medical Group - Heart Rhythm Specialists	Wauwatosa	Wisconsin	United States	53226
111	Instituto Argentino de Diagnostico y Tratamiento	Caba	Buenos Aires	Argentina	C1122AAL
112	Fundacion Favaloro para la Docencia e Inv. med.	Buenos Aires	Rio De La Plata	Argentina	C1093AAS
113	Instituto Cardiovascular Buenos Aires (ICBA)	Buenos Aires	Rio De La Plata	Argentina	C1428ART
114	Fundacion Clinica Shaio	Bogota	Antioquia	Colombia	110111
115	APEX Foundation	Medellin	Antioquia	Colombia	1104
116	Hirosaki University Hospital	Hirosaki	Aomori	Japan	0368203
117	Kokura Memorial Hospital	Kitakyushu	Fukuoka	Japan	8020001
118	Akashi Medical Center	Hyogo	Kinki	Japan	6740063
119	Tohoku University Hospital	Sendai	Miyagi	Japan	9808574
120	Tokyo Women's Medical University	Shinjuku-Ku	Tokyo	Japan	1628666
121	Chiba University	Chiba		Japan	2608677
122	St. Marianna University School of Medicine Hospital	Kanagawa		Japan	2168511
123	Shinshu University Hospital	Matsumoto		Japan	3908621
124	Niigata University Medical & Dental Hospital	Niigata		Japan	9518510
125	Sakurabashi Watanabe Hospital	Osaka		Japan	5300001
126	National Cerebral and Cardiovascular Center Hospital	Osaka		Japan	5658565
127	Osaka University Hospital	Osaka		Japan	6560871
128	University of Tsukuba Hospital	Tsukuba		Japan	3058576

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Clay Cohorn, Abbott Medical Devices

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02832622
• Other Study ID Numbers: SJM-CIP-10149
• First Posted: Jul 14, 2016
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Abbott Medical Devices: MultiPoint Pacing; Heart Failure; Cardiac Resynchronization Therapy; SJM Quadripolar Biventricular Pacing
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Pre-assignment Detail	This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group and the associated results presented.

Arm/Group Title	MPP Programming
Arm/Group Description	Data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
Period Title: Overall Study
STARTED	2169
COMPLETED	433
NOT COMPLETED	1736

Baseline Characteristics

Arm/Group Title	MPP Group
Arm/Group Description	MPP Group: Subjects programmed with MPP in the study are included in the analysis population.
Overall Participants	433
Age (Age) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Age]	70.4 (10.7)
Sex: Female, Male (Count of Participants)
Female	117 27%
Male	316 73%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	338 78.1%
Black or African American	35 8.1%
Asian	19 4.4%
Hispanic or Latino	34 7.9%
Other	7 1.6%
Region of Enrollment (participants) [Number]
Colombia	3 0.7%
Argentina	4 0.9%
United States	414 95.6%
Japan	12 2.8%
Quality of Life (MLWHF) (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	39.9 (28.1)
Left Ventricular Ejection Fraction (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	29.7 (10.4)
Left Ventricular End-Systolic Volume (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	113.9 (67.7)

Outcome Measures

1. Primary Outcome

Title	Number of CRT Responders as Measured by the Clinical Composite Score (CCS)
Description	The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Count of Participants [Participants]	350 80.8%

2. Other Pre-specified Outcome

Title	Change in Quality of Life
Description	The change in the Minnesota Living with Heart Failure (MLWHF) questionnaire score between baseline and 12 months (12 months - baseline). MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	406
Mean (Standard Deviation) [score on a scale]	-17.4 (24.4)

3. Other Pre-specified Outcome

Title	Duration of MPP Programming in Months
Description	The duration of MPP programming in months in the treatment groups.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Mean (Standard Deviation) [Months]	10.43 (2.58)

4. Other Pre-specified Outcome

Title	Number of MPP Programming Optimizations Per Subject
Description	The number of MPP programming optimizations per subject
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Mean (Standard Deviation) [programming optimizations]	0.73 (0.74)

5. Other Pre-specified Outcome

Title	Number of Subjects With Heart Failure Hospitalization
Description	HF event is defined as any one of the following when the subject has symptoms and/or signs consistent with congestive heart failure: Hospitalization for HF ≥ 24 hours Clinic or hospital visit for HF<24 hours (i.e. outpatient treatment, observational care, ER, Urgent Care and physician's office visit) requiring administration of IV diuretics, inotropes, and/or vasodilators
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Count of Participants [Participants]	57 13.2%

6. Other Pre-specified Outcome

Title	Number of Subjects With Cardiovascular Hospitalization
Description	Number of subjects with cardiovascular hospitalization as reported by the sites
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Count of Participants [Participants]	142 32.8%

7. Other Pre-specified Outcome

Title	Number of Subjects With Heart Failure 30-day Hospitalization
Description	Number of subjects with heart failure 30-day hospitalization as reported by the sites
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	433
Count of Participants [Participants]	6 1.4%

8. Other Pre-specified Outcome

Title	Number of Deaths
Description	Overall mortality rate for all subjects who started the trial is summarized.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects who started the trial.

Arm/Group Title	MPP Programming
Arm/Group Description	Overall mortality rate for all subjects who started the trial is summarized.
Measure Participants	2169
Count of Participants [Participants]	135 31.2%

9. Other Pre-specified Outcome

Title	Change in Left Ventricular Ejection Fraction
Description	Change in left ventricular ejection fraction between baseline and 12 months (12 months - baseline)
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP. LVEF was optional data point in the study. Results were available from a very small number of subjects.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	81
Mean (Standard Deviation) [percentage]	11.9 (12.0)

10. Other Pre-specified Outcome

Title	Change in Left Ventricular End Systolic Volume
Description	Change in left ventricular end systolic volume between baseline and 12 months (Baseline - 12 months)
Time Frame	baseline and one year

Outcome Measure Data

Analysis Population Description

The analysis population includes any subjects whose device is programmed with MPP. LVESV was optional data point in the study. Results were available from a very small number of subjects.

Arm/Group Title	MPP Group
Arm/Group Description	Subjects programmed with MPP in the study are included in the analysis population.
Measure Participants	20
Mean (Standard Deviation) [mL]	22.5 (57.3)

Adverse Events

Time Frame	12 months
Arm/Group Title	Overall Study Cohort
Arm/Group Description	All patients who started in the study are included in the all-cause mortality, serious adverse events and/or other adverse events tables.
All Cause Mortality
	Overall Study Cohort
	Affected / at Risk (%)	# Events
Total	135/2169 (6.2%)
Serious Adverse Events
	Overall Study Cohort
	Affected / at Risk (%)	# Events
Total	821/2169 (37.9%)
Blood and lymphatic system disorders
Abnormal Labs	1/2169 (0%)	1
Anemia	2/2169 (0.1%)	2
Deep Vein Thrombosis	1/2169 (0%)	1
Cardiac disorders
Angina	2/2169 (0.1%)	2
Aortic Insufficiency	1/2169 (0%)	1
Aortic Stenosis	1/2169 (0%)	1
Atherosclerotic Cardiovascular Disease	1/2169 (0%)	1
Cardiac Arrest	12/2169 (0.6%)	12
Cardiac Arrhythmias	72/2169 (3.3%)	80
Cardiac Sarcoidosis	1/2169 (0%)	1
Cardiac Tamponade	2/2169 (0.1%)	2
Cardiogenic Shock	6/2169 (0.3%)	6
Carotid Stenosis	1/2169 (0%)	1
Chest Pain	10/2169 (0.5%)	10
Dilated Cardiomyopathy	3/2169 (0.1%)	3
Heart Failure Exacerbation	168/2169 (7.7%)	227
Hypotension	5/2169 (0.2%)	5
Hypotensive Shock	1/2169 (0%)	1
Lightheadedness	1/2169 (0%)	1
Loss Of Capture	1/2169 (0%)	1
Mitral Regurgitation	1/2169 (0%)	1
Multi-Organ Failure	1/2169 (0%)	1
Myocardial Infarction	3/2169 (0.1%)	3
Non-St-Elevation Myocardial Infarction	12/2169 (0.6%)	14
Pericardial Effusion	2/2169 (0.1%)	2
Pulmonary Edema	1/2169 (0%)	1
Syncope	2/2169 (0.1%)	2
Valve Damage	2/2169 (0.1%)	2
Ear and labyrinth disorders
Heart Failure Exacerbation	1/2169 (0%)	1
Endocrine disorders
Abnormal Labs	1/2169 (0%)	1
Gastrointestinal disorders
Bowel Obstruction	1/2169 (0%)	1
Cholelithiasis	1/2169 (0%)	1
Diarrhea	1/2169 (0%)	1
Diverticulitis	1/2169 (0%)	1
Excessive Bleeding	4/2169 (0.2%)	4
Gallstone	1/2169 (0%)	1
Gastroenteritis	1/2169 (0%)	1
Gastrointestinal Bleeding	12/2169 (0.6%)	12
Pancreatitis	2/2169 (0.1%)	2
Peritonits	1/2169 (0%)	1
General disorders
Diabetes	1/2169 (0%)	1
Dehydration	1/2169 (0%)	1
Abnormal Labs	2/2169 (0.1%)	2
Accidental Injury	2/2169 (0.1%)	2
Allergic Reaction	2/2169 (0.1%)	3
Altered Mental Status	4/2169 (0.2%)	4
Anemia	7/2169 (0.3%)	7
Ascites	1/2169 (0%)	1
Cardiac Arrest	7/2169 (0.3%)	7
Cardiac Arrhythmias	4/2169 (0.2%)	4
Cardio-Respiratory Failure	1/2169 (0%)	1
Chest Pain	13/2169 (0.6%)	13
Confusion	1/2169 (0%)	1
Death	3/2169 (0.1%)	3
Dehydration	2/2169 (0.1%)	2
Device Discharge	1/2169 (0%)	1
Diarrhea	1/2169 (0%)	1
Drug Toxicity	2/2169 (0.1%)	2
Dyspnea	4/2169 (0.2%)	5
Encephalopathy	3/2169 (0.1%)	3
Excessive Bleeding	2/2169 (0.1%)	2
Gastrointestinal Bleeding	1/2169 (0%)	1
Heart Failure Exacerbation	5/2169 (0.2%)	5
Hematoma/Seroma	3/2169 (0.1%)	3
Hepato-Renal Failure	1/2169 (0%)	1
Hernia	2/2169 (0.1%)	2
Hypertension	1/2169 (0%)	1
Hypotension	6/2169 (0.3%)	6
Hypoxia	2/2169 (0.1%)	2
Medication Error	1/2169 (0%)	1
Metabolic Bone Disease	1/2169 (0%)	1
Multi-Organ Failure	3/2169 (0.1%)	3
Myocardial Infarction	1/2169 (0%)	1
Nausea and Vomiting	1/2169 (0%)	1
Non-Cardiac Death	1/2169 (0%)	1
Pain	2/2169 (0.1%)	2
Pericardial Effusion	2/2169 (0.1%)	2
Pleural Effusion	5/2169 (0.2%)	5
Pre-Syncope	1/2169 (0%)	1
Pulmonary Edema	6/2169 (0.3%)	6
Renal Failure	4/2169 (0.2%)	4
Respiratory Failure	9/2169 (0.4%)	9
Rhabdomyolysis	1/2169 (0%)	1
Sepsis	1/2169 (0%)	1
Syncope	6/2169 (0.3%)	6
Twiddler's Syndrome	1/2169 (0%)	1
Unresponsiveness	1/2169 (0%)	1
Weakness	2/2169 (0.1%)	2
Hepatobiliary disorders
Acute Hepatitis	1/2169 (0%)	1
Cholelithiasis	1/2169 (0%)	1
Cirrhosis	1/2169 (0%)	1
Dyspnea	1/2169 (0%)	1
Hepatitis	1/2169 (0%)	1
Immune system disorders
Allergic Reaction	1/2169 (0%)	1
Infections and infestations
Endocarditis	2/2169 (0.1%)	2
Infection	80/2169 (3.7%)	90
Pneumonia	5/2169 (0.2%)	5
Sepsis	11/2169 (0.5%)	11
Septic Shock	1/2169 (0%)	1
Injury, poisoning and procedural complications
Accidental Injury	18/2169 (0.8%)	18
Cardiac Arrhythmias	1/2169 (0%)	1
Cardiac Tamponade	5/2169 (0.2%)	5
Cardiac/Coronary Sinus Dissection	1/2169 (0%)	1
Cardiac/Coronary Sinus Perforation	4/2169 (0.2%)	4
Deep Vein Thrombosis	1/2169 (0%)	1
Drug Overdose	1/2169 (0%)	1
Excessive Bleeding	2/2169 (0.1%)	2
Hematoma/Seroma	12/2169 (0.6%)	12
Infection	3/2169 (0.1%)	3
Pain	1/2169 (0%)	1
Pericarditis	1/2169 (0%)	1
Pneumothorax/Hemothorax	7/2169 (0.3%)	7
Pulmonary Edema	1/2169 (0%)	1
Pulmonary Hemorrhage	1/2169 (0%)	1
Renal Failure From Contrast Media Used To Visualize Coronary Veins	1/2169 (0%)	1
Thrombolytic or Air Embolism	2/2169 (0.1%)	2
Wound Site Complications	2/2169 (0.1%)	2
Investigations
Abnormal Labs	3/2169 (0.1%)	3
Chest Pain	1/2169 (0%)	1
Drug Toxicity	1/2169 (0%)	1
Induced Atrial or Ventricular Arrhythmias	1/2169 (0%)	1
Rise in Threshold and Exit Block	1/2169 (0%)	1
Musculoskeletal and connective tissue disorders
Accidental Injury	2/2169 (0.1%)	2
Arthritis	1/2169 (0%)	1
Osteoarthritis	2/2169 (0.1%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Polyps	1/2169 (0%)	1
Tumor	14/2169 (0.6%)	14
Nervous system disorders
Cerebellar Hemorrhage	2/2169 (0.1%)	2
Cerebral Hemorrhage	1/2169 (0%)	1
Cerebrovascular Accident	2/2169 (0.1%)	2
Glioblastoma	1/2169 (0%)	1
Stroke	3/2169 (0.1%)	3
Product Issues
Cardiac Arrhythmias	1/2169 (0%)	1
Cardiac/Coronary Sinus Perforation	1/2169 (0%)	1
Change in Thresholds	3/2169 (0.1%)	3
Device Malfunction	1/2169 (0%)	1
Elevated Defibrillation Threshold	1/2169 (0%)	1
Induced Atrial or Ventricular Arrhythmias	1/2169 (0%)	1
Infection	1/2169 (0%)	1
Lead Dislodgement	35/2169 (1.6%)	38
Lead/Port Damage	1/2169 (0%)	1
Loss of Capture	2/2169 (0.1%)	2
Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead	5/2169 (0.2%)	5
Oversensing	1/2169 (0%)	1
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation	1/2169 (0%)	1
Rise in Threshold And Exit Block	1/2169 (0%)	1
Psychiatric disorders
Depression	1/2169 (0%)	1
Renal and urinary disorders
Cholecystitis	1/2169 (0%)	1
Dialysis Shunt Occlusion	1/2169 (0%)	1
Kidney Stones	1/2169 (0%)	1
Nephrolithiasis	4/2169 (0.2%)	4
Renal Failure	20/2169 (0.9%)	23
Renal Transplantation	1/2169 (0%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	13/2169 (0.6%)	14
Pleural Effusion	1/2169 (0%)	1
Pulmonary Edema	3/2169 (0.1%)	3
Pulmonary Embolism	1/2169 (0%)	1
Respiratory Failure	6/2169 (0.3%)	10
Social circumstances
Accidental Injury	1/2169 (0%)	1
Surgical and medical procedures
Wound Site Complications	1/2169 (0%)	1
Vascular disorders
Aneurysm	3/2169 (0.1%)	3
AV Fistula	1/2169 (0%)	1
Carotid Stenosis	2/2169 (0.1%)	2
Cerebrovascular Accident	4/2169 (0.2%)	4
Deep Vein Thrombosis	3/2169 (0.1%)	3
Excessive Bleeding	1/2169 (0%)	1
Limb Ischemia	1/2169 (0%)	1
Occluded Stent	1/2169 (0%)	1
Peripheral Artery Disease	1/2169 (0%)	1
Peripheral Vascular Disease	1/2169 (0%)	1
Ruptured Abdominal Aortic Aneurysm	1/2169 (0%)	1
Stroke	6/2169 (0.3%)	6
Thrombolytic or Air Embolism	3/2169 (0.1%)	3
Transient Ischemic Attack	1/2169 (0%)	1
Ulcer	1/2169 (0%)	1
Other (Not Including Serious) Adverse Events
	Overall Study Cohort
	Affected / at Risk (%)	# Events
Total	288/2169 (13.3%)
Blood and lymphatic system disorders
Thrombolytic or Air Embolism	1/2169 (0%)	1
Cardiac disorders
Cardiac Arrhythmias	7/2169 (0.3%)	7
Dyspnea	1/2169 (0%)	1
Heart Failure Exacerbation	4/2169 (0.2%)	4
General disorders
Lead Dislodgement	3/2169 (0.1%)	3
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation	9/2169 (0.4%)	9
Allergic Reaction	3/2169 (0.1%)	3
Altered Mental Status	1/2169 (0%)	1
Change in Thresholds	1/2169 (0%)	1
Chest Pain	2/2169 (0.1%)	2
Device Vibration	1/2169 (0%)	1
Dizziness	1/2169 (0%)	1
Dyspnea	1/2169 (0%)	1
Hematoma/Seroma	3/2169 (0.1%)	3
Hypertension	1/2169 (0%)	1
Hypotension	2/2169 (0.1%)	2
Lead Dislodgement	1/2169 (0%)	1
Loss of Capture	2/2169 (0.1%)	2
Pain	4/2169 (0.2%)	4
Loss Of CapturePectoral/Diaphragmatic/Phrenic Nerve Stimulation	7/2169 (0.3%)	8
Pre-Syncope	1/2169 (0%)	1
Syncope	1/2169 (0%)	1
Weakness	1/2169 (0%)	1
Infections and infestations
Infection	3/2169 (0.1%)	3
Injury, poisoning and procedural complications
Accidental Injury	2/2169 (0.1%)	2
Anemia	2/2169 (0.1%)	2
Cardiac/Coronary Sinus Dissection	5/2169 (0.2%)	5
Deep Vein Thrombosis	1/2169 (0%)	1
Excessive Bleeding	3/2169 (0.1%)	3
Hematoma/Seroma	13/2169 (0.6%)	13
Infection	1/2169 (0%)	1
Pain	3/2169 (0.1%)	3
Pericardial Effusion	2/2169 (0.1%)	2
Pseudoaneurysm	1/2169 (0%)	1
Thrombolytic or Air Embolism	1/2169 (0%)	1
Transient Ischemic Attack	1/2169 (0%)	1
Wound Site Complications	3/2169 (0.1%)	3
Investigations
Increased Impedance	1/2169 (0%)	1
Induced Atrial or Ventricular Arrhythmias	1/2169 (0%)	1
Product Issues
Change in Thresholds	22/2169 (1%)	23
Device Discharge	1/2169 (0%)	1
Inappropriate Therapy	2/2169 (0.1%)	2
Induced Atrial or Ventricular Arrhythmias	1/2169 (0%)	1
Lead Dislodgement	32/2169 (1.5%)	32
Lead/Port Damage	1/2169 (0%)	1
Loss of Capture	12/2169 (0.6%)	12
Loss of Pacing and/or Sensing due to Dislodgement or Mechanical Malfunction of The Pacing Lead	7/2169 (0.3%)	7
LV Lead Stylet Malfunction	1/2169 (0%)	1
Oversensing	1/2169 (0%)	1
Pectoral/Diaphragmatic/Phrenic Nerve Stimulation	104/2169 (4.8%)	124
Rise in Threshold and Exit Block	1/2169 (0%)	1
Vascular disorders
Deep Vein Thrombosis	2/2169 (0.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.