Trial Outcomes & Findings for Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™ (NCT NCT03247829)
NCT ID: NCT03247829
Last Updated: 2024-04-26
Results Overview
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Recruitment status
COMPLETED
Target enrollment
101 participants
Primary outcome timeframe
Six Months
Results posted on
2024-04-26
Participant Flow
The study enrolled a total of 101 subjects at 22 investigational sites in the United States. The first subject was enrolled on 24 August 2017 and enrollment was completed on 20 August 2019. The last 6-month follow-up was completed on 6 March 2020. Data was collected until the database closure date, 3 April 2020.
Participant milestones
| Measure |
Group A
Patients with both a CardioMEMS PA Sensor and HeartMate II or HeartMate 3 Left Ventricular Assist Device (LVAD) previously implanted, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System
|
Group B
Patients with a HeartMate II or HeartMate 3 LVAD previously implanted who are implanted with a CardioMEMS PA Sensor within 72 hours of enrollment, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
48
|
|
Overall Study
COMPLETED
|
46
|
42
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Group A
Patients with both a CardioMEMS PA Sensor and HeartMate II or HeartMate 3 Left Ventricular Assist Device (LVAD) previously implanted, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System
|
Group B
Patients with a HeartMate II or HeartMate 3 LVAD previously implanted who are implanted with a CardioMEMS PA Sensor within 72 hours of enrollment, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System.
|
|---|---|---|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Enter Hospice Care
|
1
|
0
|
|
Overall Study
LVAD System Replaced / Exchange
|
1
|
0
|
|
Overall Study
LVAD Explant
|
1
|
1
|
|
Overall Study
Transplant
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A
n=53 Participants
Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS
Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges
|
Group B
n=48 Participants
Patients with LVAD to implant CardioMEMS device within 72 hours of enrollment, will receive hemodynamic management using CardioMEMS
Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 11.4 • n=53 Participants
|
59.9 years
STANDARD_DEVIATION 13.6 • n=48 Participants
|
61.2 years
STANDARD_DEVIATION 12.5 • n=101 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=53 Participants
|
11 Participants
n=48 Participants
|
25 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=53 Participants
|
37 Participants
n=48 Participants
|
76 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
53 participants
n=53 Participants
|
48 participants
n=48 Participants
|
101 participants
n=101 Participants
|
|
Ischemic Cardiomyopathy
|
25 Participants
n=53 Participants
|
22 Participants
n=48 Participants
|
47 Participants
n=101 Participants
|
|
Body Mass Index (BMI)
|
32.31 kg/m^2
STANDARD_DEVIATION 7.78 • n=53 Participants
|
34.08 kg/m^2
STANDARD_DEVIATION 7.52 • n=48 Participants
|
33.15 kg/m^2
STANDARD_DEVIATION 7.67 • n=101 Participants
|
|
Systemic Systolic Pressure
|
100.6 mmHg
STANDARD_DEVIATION 30.4 • n=19 Participants • Systemic Systolic Pressure was not acquired from all patients at baseline.
|
105.7 mmHg
STANDARD_DEVIATION 14.9 • n=23 Participants • Systemic Systolic Pressure was not acquired from all patients at baseline.
|
103.4 mmHg
STANDARD_DEVIATION 23.1 • n=42 Participants • Systemic Systolic Pressure was not acquired from all patients at baseline.
|
|
Systemic Diastolic Pressure
|
64.7 mmHg
STANDARD_DEVIATION 26.6 • n=18 Participants • Systemic Diastolic Pressure was not acquired from all patients at baseline.
|
72.6 mmHg
STANDARD_DEVIATION 20.3 • n=23 Participants • Systemic Diastolic Pressure was not acquired from all patients at baseline.
|
69.1 mmHg
STANDARD_DEVIATION 23.3 • n=41 Participants • Systemic Diastolic Pressure was not acquired from all patients at baseline.
|
|
Heart Rate
|
79.2 beats per minute
STANDARD_DEVIATION 17.8 • n=52 Participants • Heart Rate was not acquired from all patients at baseline.
|
78.6 beats per minute
STANDARD_DEVIATION 16.1 • n=48 Participants • Heart Rate was not acquired from all patients at baseline.
|
78.9 beats per minute
STANDARD_DEVIATION 16.9 • n=100 Participants • Heart Rate was not acquired from all patients at baseline.
|
|
NYHA Functional Class
NYHA Class I
|
2 Participants
n=53 Participants
|
0 Participants
n=48 Participants
|
2 Participants
n=101 Participants
|
|
NYHA Functional Class
NYHA Class II
|
19 Participants
n=53 Participants
|
6 Participants
n=48 Participants
|
25 Participants
n=101 Participants
|
|
NYHA Functional Class
NYHA Class III
|
28 Participants
n=53 Participants
|
42 Participants
n=48 Participants
|
70 Participants
n=101 Participants
|
|
NYHA Functional Class
NYHA Class IV
|
4 Participants
n=53 Participants
|
0 Participants
n=48 Participants
|
4 Participants
n=101 Participants
|
|
Six Minute Walk Distance
|
252.08 meters
STANDARD_DEVIATION 136.17 • n=53 Participants • Six Minute Hall Walk was not acquired from all patients at baseline.
|
243.76 meters
STANDARD_DEVIATION 109.58 • n=45 Participants • Six Minute Hall Walk was not acquired from all patients at baseline.
|
248.26 meters
STANDARD_DEVIATION 124.11 • n=98 Participants • Six Minute Hall Walk was not acquired from all patients at baseline.
|
|
EQ-5D-5L VAS
|
70.3 score on a scale
STANDARD_DEVIATION 19.1 • n=53 Participants • EQ-5D-5L VAS test was not obtained from all patients at baseline.
|
66.2 score on a scale
STANDARD_DEVIATION 20.6 • n=46 Participants • EQ-5D-5L VAS test was not obtained from all patients at baseline.
|
68.4 score on a scale
STANDARD_DEVIATION 19.8 • n=99 Participants • EQ-5D-5L VAS test was not obtained from all patients at baseline.
|
PRIMARY outcome
Timeframe: Six MonthsPopulation: Six minute hall walk distance measured at 6 months compared to baseline.
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Outcome measures
| Measure |
Group A
n=46 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=42 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Six Minute Hall Walk (6MHW) Distance
|
-44.9 meters
Standard Deviation 135.0
|
69.7 meters
Standard Deviation 100.6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsPopulation: Change in PA Diastolic pressure from baseline to 6 months.
Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up.
Outcome measures
| Measure |
Group A
n=37 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=33 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Change in PA Diastolic Pressure From Baseline to 6 Months
|
0.6 mmHg
Standard Deviation 4.2
|
-1.7 mmHg
Standard Deviation 5.6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsAverage number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis.
Outcome measures
| Measure |
Group A
n=101 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Days PA Diastolic Pressure is in the Pre-specified Target Range
|
28.2 days
Standard Deviation 39.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test.
Outcome measures
| Measure |
Group A
n=44 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=39 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
n=38 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
n=35 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
PA Diastolic Pressure Before 6MHW Test to After 6MHW Test
|
13.9 mmHg
Standard Deviation 7.2
|
16.3 mmHg
Standard Deviation 6.8
|
15.8 mmHg
Standard Deviation 8.2
|
19.8 mmHg
Standard Deviation 10.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsPopulation: All patients with LVAD and CardioMEMS device in place.
Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis.
Outcome measures
| Measure |
Group A
n=101 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions
No Device Malfunction (HM II & HM3)
|
99 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions
Pump thrombosis (HM II)
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions
Driveline fracture (HM II)
|
1 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsPopulation: NYHA class as a continuous variable in which the change in NYHA class is calculated using: NYHA class I =1, class II = 2, class IIIa/IIIb = 3, class IV = 4 and death =5.
Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Outcome measures
| Measure |
Group A
n=53 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=48 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
New York Heart Association (NYHA) Classification
|
0.12 Change in NYHA Class
Interval -0.11 to 0.35
|
-0.10 Change in NYHA Class
Interval -0.32 to 0.11
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsPopulation: Change in EQ-5D-5L VAS scores from baseline to 6 months.
Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis.
Outcome measures
| Measure |
Group A
n=53 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=48 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
EQ-5D-5L VAS
|
-1.4 Change in score
Interval -7.7 to 4.9
|
3.0 Change in score
Interval -3.2 to 9.1
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsNumber and percent of participants who were hospitalized for any cause during follow-up.
Outcome measures
| Measure |
Group A
n=53 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=48 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Number and Percent of Participants With All-cause Hospitalizations.
|
27 Participants
|
25 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: six monthsWorsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management.
Outcome measures
| Measure |
Group A
n=53 Participants
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment.
Patients with CardioMEMS PA Sensor and LVAD, previously implanted, received hemodynamic management using CardioMEMS HF System.
|
Group B
n=48 Participants
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Pre 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
Group B Post 6MHW Test
Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment.
Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System.
|
|---|---|---|---|---|
|
Number and Percent of Participants With Worsening Heart Failure Events
|
10 Participants
|
14 Participants
|
—
|
—
|
Adverse Events
All Patients
Serious events: 36 serious events
Other events: 3 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
All Patients
n=101 participants at risk
Patients with both an LVAD and CardioMEMS device in place. All safety assessments were made on a population basis, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis.
|
|---|---|
|
Cardiac disorders
Worsening Heart Failure
|
19.8%
20/101 • Number of events 23 • 6 months
|
|
Cardiac disorders
Syncope/presyncope/dizziness and hypovolemia
|
10.9%
11/101 • Number of events 14 • 6 months
|
|
Cardiac disorders
Cardiac arrhythmias
|
5.0%
5/101 • Number of events 6 • 6 months
|
|
Cardiac disorders
Right heart failure
|
5.0%
5/101 • Number of events 5 • 6 months
|
|
Renal and urinary disorders
Renal dysfunction secondary to heart failure
|
3.0%
3/101 • Number of events 4 • 6 months
|
|
Nervous system disorders
Other neurological event
|
2.0%
2/101 • Number of events 2 • 6 months
|
|
Vascular disorders
Respiratory failure secondary to cardiovascular cause
|
0.99%
1/101 • Number of events 1 • 6 months
|
|
Nervous system disorders
Strokes regardless of their type and etiology
|
0.99%
1/101 • Number of events 1 • 6 months
|
|
General disorders
Other
|
4.0%
4/101 • Number of events 5 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 2 • 6 months
|
|
Cardiac disorders
Hypotension
|
0.99%
1/101 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Over-diuresis
|
0.99%
1/101 • Number of events 1 • 6 months
|
|
Cardiac disorders
Volume Overload
|
0.99%
1/101 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
All Patients
n=101 participants at risk
Patients with both an LVAD and CardioMEMS device in place. All safety assessments were made on a population basis, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis.
|
|---|---|
|
Cardiac disorders
Non-serious Adverse Device Effects
|
3.0%
3/101 • Number of events 3 • 6 months
|
Additional Information
Dr. Marie-Elena Brett, PhD; Principal Scientist Clinical Research
Abbott_Medical_Devices
Phone: 17815283613
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place