Trial Outcomes & Findings for MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (NCT NCT02006069)
NCT ID: NCT02006069
Last Updated: 2023-05-17
Results Overview
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5850 participants
Primary outcome timeframe
Non-responder to responder conversion rate between randomization at 6 months and 12 months
Results posted on
2023-05-17
Participant Flow
The study enrolled eligible patients with a standard CRT indication after obtaining written informed consent. The implanting physician programmed biventricular pacing (BiVP) at implant in those patients who had the quadripolar CRT system successfully implanted The implanting physician programmed the LV pacing vector, A-V delay, and V-V delay settings at their discretion until the patient's randomization at 6 months.
For the first 6 months post-implant, all enrolled patients were followed with traditional biventricular pacing (BiVP). Only patients not responding to BiVP between baseline and 6 months (using LVESV reduction less than 15%), which is called CRT non-responders, were randomized to either MPP or continuous BiVP arm at 6 months and followed until 12 months.
Participant milestones
| Measure |
MPP ON
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.
The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
|
BiVP
MPP OFF: Continuous BiVP after 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
510
|
558
|
|
Overall Study
COMPLETED
|
271
|
555
|
|
Overall Study
NOT COMPLETED
|
239
|
3
|
Reasons for withdrawal
| Measure |
MPP ON
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.
The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
|
BiVP
MPP OFF: Continuous BiVP after 6 months
|
|---|---|---|
|
Overall Study
MPP other programming
|
239
|
0
|
|
Overall Study
RV only pacing
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MPP ON
n=271 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=555 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
Total
n=826 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 10.3 • n=271 Participants
|
68.1 years
STANDARD_DEVIATION 10.6 • n=555 Participants
|
68.2 years
STANDARD_DEVIATION 10.5 • n=826 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=271 Participants
|
123 Participants
n=555 Participants
|
168 Participants
n=826 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=271 Participants
|
432 Participants
n=555 Participants
|
658 Participants
n=826 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Cardiomyopathy
Ischemic
|
147 Participants
n=271 Participants
|
278 Participants
n=555 Participants
|
425 Participants
n=826 Participants
|
|
Type of Cardiomyopathy
Non-ischemic
|
124 Participants
n=271 Participants
|
277 Participants
n=555 Participants
|
401 Participants
n=826 Participants
|
|
NYHA Class
II
|
129 Participants
n=271 Participants
|
272 Participants
n=555 Participants
|
401 Participants
n=826 Participants
|
|
NYHA Class
III
|
137 Participants
n=271 Participants
|
268 Participants
n=555 Participants
|
405 Participants
n=826 Participants
|
|
NYHA Class
IV
|
4 Participants
n=271 Participants
|
13 Participants
n=555 Participants
|
17 Participants
n=826 Participants
|
|
NYHA Class
Not done
|
1 Participants
n=271 Participants
|
2 Participants
n=555 Participants
|
3 Participants
n=826 Participants
|
PRIMARY outcome
Timeframe: Non-responder to responder conversion rate between randomization at 6 months and 12 monthsThe primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Outcome measures
| Measure |
MPP ON
n=271 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=555 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Percentage of Non-responder Patients Who Converted to Responders
|
84 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: Baseline vs 6 MonthsReduction of LVESV between baseline and 6 Months visit
Outcome measures
| Measure |
MPP ON
n=271 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=555 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
|
2.1 percentage of LVESV change
Standard Deviation 11.2
|
0.1 percentage of LVESV change
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline vs 12 MonthsPacker's Clinical Composite Score evaluation between baseline and 12 months as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
Outcome measures
| Measure |
MPP ON
n=271 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=555 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Clinical Composite Score Evaluation
Improved
|
161 Participants
|
312 Participants
|
|
Clinical Composite Score Evaluation
Unchanged
|
56 Participants
|
124 Participants
|
|
Clinical Composite Score Evaluation
Worsensed
|
54 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: Baseline vs 12 MonthsPopulation: Only subjects with LVESV data available at both baseline and 12 months were included in this analysis.
Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
Outcome measures
| Measure |
MPP ON
n=267 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=538 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Reverse Left Ventricular (LV) Remodeling
|
3.0 mL
Standard Deviation 24
|
3.8 mL
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline vs 12 MonthsPopulation: Only subjects with NYHA data available at both baseline and 12 months were included in this analysis.
Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
Outcome measures
| Measure |
MPP ON
n=266 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=532 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
NYHA Class Changes
Improved
|
125 Participants
|
287 Participants
|
|
NYHA Class Changes
Unchanged
|
129 Participants
|
225 Participants
|
|
NYHA Class Changes
Worsened
|
12 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline vs 12 MonthsPopulation: Only subjects with 6MHWT data available at both baseline and 12 months were included in this analysis.
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Outcome measures
| Measure |
MPP ON
n=221 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=441 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
6MWT Changes
|
41.1 meters
Standard Deviation 113.6
|
46 meters
Standard Deviation 121.1
|
SECONDARY outcome
Timeframe: Baseline vs 12 MonthsPopulation: Only subjects with MLWHF data available at both baseline and 12 months were included in this analysis.
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
Outcome measures
| Measure |
MPP ON
n=261 Participants
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BiVP
n=523 Participants
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Patient's QoL Score Changes (MLWHF)
|
-11.6 score on a scale
Standard Deviation 20.0
|
-12.2 score on a scale
Standard Deviation 21.7
|
Adverse Events
MPP ON
Serious events: 82 serious events
Other events: 67 other events
Deaths: 4 deaths
BIVP
Serious events: 190 serious events
Other events: 118 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
MPP ON
n=271 participants at risk
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BIVP
n=555 participants at risk
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Blood and lymphatic system disorders
Anticoagulant Overdose
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Blood and lymphatic system disorders
Hemopathy
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Acute Myocarditis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Atrial or Ventricular Arrhythmia
|
8.5%
23/271 • Number of events 28 • 6 months to 12 months after randomization
|
7.6%
42/555 • Number of events 60 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiogenic Shock
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 4 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiomyopathy
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiorespiratory Arrest
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Coronary Artery Disease
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.90%
5/555 • Number of events 5 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Exacerbation of Heart Failure
|
11.1%
30/271 • Number of events 40 • 6 months to 12 months after randomization
|
9.5%
53/555 • Number of events 76 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Heart Block
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Mitral Valve Dysfunction
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Myocardial Infarction
|
0.74%
2/271 • Number of events 4 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pacemaker Mediated Tachycardia
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pain
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pericardial Effusion
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pulmonary Edema
|
1.5%
4/271 • Number of events 5 • 6 months to 12 months after randomization
|
1.3%
7/555 • Number of events 8 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Sudden Cardiac Death
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Valve Damage
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Congenital, familial and genetic disorders
Exacerbation of Heart Failure
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Endocrine disorders
Hyperthyroidism Caused by Amiodarone
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Ear and labyrinth disorders
Cataract
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Abdominal Affliction
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Bleeding/Hematoma/Seroma
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Downhill Varicose and Diverticulum
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Esophageal Varices
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
GI Bleed
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Gastrointestinal Disease
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Obstipation
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Pancreatic Cystic Lesion
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
General disorders
Drug Side Effect
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
General disorders
Infection
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
General disorders
Nausea, Vomiting
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
General disorders
Pain
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
General disorders
Pain at Pulse Generator Site
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Hepatobiliary disorders
Gallbladder Disease
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Hepatobiliary disorders
Liver Injury
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Immune system disorders
Drug Allergy
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Immune system disorders
Interstitial Pulmonary Fibrosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Infections and infestations
Infection
|
2.6%
7/271 • Number of events 8 • 6 months to 12 months after randomization
|
2.9%
16/555 • Number of events 21 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Bleeding/Hematoma/Seroma
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Cardiac Perforation
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Coronary Sinus Dissection
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.72%
4/555 • Number of events 4 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Erosion
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Fall
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Infection
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Mild Concussion
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Pain at Pulse Generator Site
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Pericardial Effusion
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Pneumothorax
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
1.1%
6/555 • Number of events 6 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Pocket Swelling
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Thrombosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Traumatic Subdural Hemorrhage
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Metabolism and nutrition disorders
Diabetes
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Metabolism and nutrition disorders
Electrolyte Disorder
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Metabolism and nutrition disorders
Fluid Accumulation
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Metabolism and nutrition disorders
Obesity
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Musculoskeletal and connective tissue disorders
Myogelosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Tumor
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Tumor
|
0.00%
0/271 • 6 months to 12 months after randomization
|
1.1%
6/555 • Number of events 6 • 6 months to 12 months after randomization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral Neoplasm
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Cerebellar Syndrome
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Dementia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Stroke
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Vertigo
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Abnormal Lead Pacing Impedance <= 200 OHMS or >=2000 OHMS
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Product Issues
Elevated Pacing Thresholds/Loss of Capture
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Infection
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Product Issues
Lead Dislodgement or Migration
|
3.0%
8/271 • Number of events 9 • 6 months to 12 months after randomization
|
6.5%
36/555 • Number of events 40 • 6 months to 12 months after randomization
|
|
Product Issues
Lead Fracture
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Oversensing
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Product Issues
Pulse Generator Migration
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Therapy for Non-Ventricular Rhythm
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 4 • 6 months to 12 months after randomization
|
|
Product Issues
Undersensing
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Psychiatric disorders
Anxiety
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Psychiatric disorders
Confusion
|
0.37%
1/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Psychiatric disorders
Dementia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Psychiatric disorders
Sleep Apnea
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 4 • 6 months to 12 months after randomization
|
|
Renal and urinary disorders
Kidney Disease
|
1.5%
4/271 • Number of events 4 • 6 months to 12 months after randomization
|
2.0%
11/555 • Number of events 12 • 6 months to 12 months after randomization
|
|
Renal and urinary disorders
Renal Disease
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Renal and urinary disorders
Urinary Tract Disease
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Larynx Perforation After Tee
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pseudo-Nodular Lung Consolidation
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disease
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Skin and subcutaneous tissue disorders
Limb Gangrene
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Surgical and medical procedures
Bone Fracture
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Surgical and medical procedures
Nose Resection
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Bleeding/Hematoma/Seroma
|
2.2%
6/271 • Number of events 7 • 6 months to 12 months after randomization
|
1.6%
9/555 • Number of events 9 • 6 months to 12 months after randomization
|
|
Vascular disorders
Bypass Graft Occlusion
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Hypotension
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Vascular disorders
Intracardiac Thrombus
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Lower Extremity Claudication
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Peripheral Artery Disease
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Vascular disorders
Syncope
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Thrombosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Vascular disorders
TIA
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Venous Occlusion
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
Other adverse events
| Measure |
MPP ON
n=271 participants at risk
MPP ON: feature is enabled after 6 months
MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.
|
BIVP
n=555 participants at risk
MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.
|
|---|---|---|
|
Cardiac disorders
Atrial or Ventricular Arrhythmia
|
8.9%
24/271 • Number of events 29 • 6 months to 12 months after randomization
|
7.4%
41/555 • Number of events 43 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Exacerbation of Heart Failure
|
1.8%
5/271 • Number of events 7 • 6 months to 12 months after randomization
|
2.3%
13/555 • Number of events 13 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Heart Transplant
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pacemaker Mediated Tachycardia
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Cardiac disorders
Pulmonary Edema
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Endocrine disorders
Hyperthyreosis
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Chest Pain
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Gastrointestinal disorders
Mild Diverticulosis
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
General disorders
Fever
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
General disorders
Pain
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
General disorders
Pain at Pulse Generator Site
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
General disorders
Worsening of General Patient's Condition
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Infections and infestations
Infection
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.72%
4/555 • Number of events 4 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Bone Fracture
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Injury, poisoning and procedural complications
Coronary Sinus Dissection
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Dizziness
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Nervous system disorders
Tremor
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Bodily Rejection Phenomena
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Product Issues
Elevated Pacing Thresholds/Loss of Capture
|
1.8%
5/271 • Number of events 6 • 6 months to 12 months after randomization
|
1.4%
8/555 • Number of events 9 • 6 months to 12 months after randomization
|
|
Product Issues
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)
|
4.8%
13/271 • Number of events 16 • 6 months to 12 months after randomization
|
4.7%
26/555 • Number of events 31 • 6 months to 12 months after randomization
|
|
Product Issues
Lead Dislodgement or Migration
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Product Issues
Oversensing
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.90%
5/555 • Number of events 6 • 6 months to 12 months after randomization
|
|
Product Issues
Pacemaker Mediated Tachycardia
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Product Issues
Palpitation
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Product Issues
Therapy for Non-Ventricular Rhythm
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Psychiatric disorders
Sleep Apnea
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Renal and urinary disorders
Kidney Disease
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disease
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Surgical and medical procedures
Elective Replacement
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.18%
1/555 • Number of events 1 • 6 months to 12 months after randomization
|
|
Vascular disorders
Bleeding/Hematoma/Seroma
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
1.8%
10/555 • Number of events 10 • 6 months to 12 months after randomization
|
|
Vascular disorders
Hypotension
|
1.1%
3/271 • Number of events 3 • 6 months to 12 months after randomization
|
0.54%
3/555 • Number of events 3 • 6 months to 12 months after randomization
|
|
Vascular disorders
Syncope
|
0.00%
0/271 • 6 months to 12 months after randomization
|
0.36%
2/555 • Number of events 2 • 6 months to 12 months after randomization
|
|
Vascular disorders
Thrombosis
|
0.37%
1/271 • Number of events 1 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
|
Vascular disorders
Venous Occlusion
|
0.74%
2/271 • Number of events 2 • 6 months to 12 months after randomization
|
0.00%
0/555 • 6 months to 12 months after randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60