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Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
trial testing Hemodynamic management using CardioMEMS HF System in Heart Failure in 101 participants. Completed in 30 June 2020.
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 101 |
| Start date | 24 August 2017 |
| Primary completion | 6 March 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 23 locations across United States |
Abbott Medical Devices — full company profile →
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Group A | -44.9 | ± 135.0 |
| Group B | 69.7 | ± 100.6 |
Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 0.6 | ± 4.2 |
| Group B | -1.7 | ± 5.6 |
Average 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.
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 28.2 | ± 39.0 |
Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test.
| Group | Value | 95% CI |
|---|---|---|
| Group A Pre 6MHW Test | 13.9 | ± 7.2 |
| Group A Post 6MHW Test | 16.3 | ± 6.8 |
| Group B Pre 6MHW Test | 15.8 | ± 8.2 |
| Group B Post 6MHW Test | 19.8 | ± 10.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| All Patients | 99 | |
| All Patients | 1 | |
| All Patients | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 0.12 | -0.11 – 0.35 |
| Group B | -0.10 | -0.32 – 0.11 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group A | -1.4 | -7.7 – 4.9 |
| Group B | 3.0 | -3.2 – 9.1 |
Number and percent of participants who were hospitalized for any cause during follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 27 | |
| Group B | 25 |
Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management.
| Group | Value | 95% CI |
|---|---|---|
| Group A | 10 | |
| Group B | 14 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Patients |
|---|---|---|
| Worsening Heart Failure | Cardiac disorders | — |
| Syncope/presyncope/dizziness and hypovolemia | Cardiac disorders | — |
| Cardiac arrhythmias | Cardiac disorders | — |
| Right heart failure | Cardiac disorders | — |
| Other | General disorders | — |
| Renal dysfunction secondary to heart failure | Renal and urinary disorders | — |
| Other neurological event | Nervous system disorders | — |
| Respiratory failure secondary to cardiovascular cause | Vascular disorders | — |
| Strokes regardless of their type and etiology | Nervous system disorders | — |
| Pneumonia | Infections and infestations | — |
| Hypotension | Cardiac disorders | — |
| Over-diuresis | Renal and urinary disorders | — |
| Volume Overload | Cardiac disorders | — |
| Reaction | System | All Patients |
|---|---|---|
| Non-serious Adverse Device Effects | Cardiac disorders | — |
Most-reported serious reactions: Worsening Heart Failure, Syncope/presyncope/dizziness and hypovolemia, Cardiac arrhythmias, Right heart failure, Other, Renal dysfunction secondary to heart failure, Other neurological event, Respiratory failure secondary to cardiovascular cause.
Data from ClinicalTrials.gov NCT03247829 adverse events section.
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
5 peer-reviewed publications reference this trial (live from Europe PMC):
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