18 and older, any sex, with Heart Failure or Heart Failure, Systolic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause MortalityPrimary· 12 months post-implantation (395 days after implant date)
The composite of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
3. The number of deaths of any cause
added together with equal weighting into a total number of events
Group
Value
95% CI
Randomized Arm - Treatment Group
0.563
Randomized Arm - Control Group
0.640
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]Primary· The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
The composite of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
3. The number of deaths of any cause
added together with equal weighting into a total number of events.
Group
Value
95% CI
Randomized Arm - Treatment Group [Pre-COVID-19]
0.553
Randomized Arm - Control Group [Pre-COVID-19]
0.682
Randomized Arm - Treatment Group [During COVID-19]
0.597
Randomized Arm - Control Group [During COVID-19]
0.536
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]Primary· 12 Months Post Implantation
The composite of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
3. The number of deaths of any cause
added together with equal weighting into a total number of events.
Group
Value
95% CI
Randomized Arm - Treatment Group (Pre-COVID-19)
0.710
Randomized Arm - Control Group (Pre-COVID-19)
0.864
Randomized Arm - Treatment Group (During COVID-19)
0.508
Randomized Arm - Control Arm (During COVID-19)
0.539
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]Primary· 12 Months Post-Implantation
The composite of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
3. The number of deaths of any cause
added together with equal weighting into a total number of events.
Group
Value
95% CI
Randomized Arm - Treatment Group [Excluding COVID-19 Related Events]
0.563
Randomized Arm - Control Group [Excluding COVID-19 Related Events]
0.633
Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events]
0.558
Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events]
0.619
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause MortalityPrimary· 12 months post-implantation (395 days after implant date)
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events
Group
Value
95% CI
Single Arm - Elevated NT-proBNP/BNP Only
0.394
Single Arm - Previous HF Hospitalization Only
0.771
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]Primary· Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events
Group
Value
95% CI
Single Arm - Elevated NT-proBNP/BNP Only [Prior to COVID-19]
0.263
Single Arm - Previous HF Hospitalization Only [Prior to COVID-19]
0.861
Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19]
0.418
Single Arm - Previous HF Hospitalization Only [During COVID-19]
0.744
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]Primary· 12 Months Post Implantation
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events
Group
Value
95% CI
Single Arm - Elevated NT-proBNP/BNP Only (Pre-COVID-19)
0.582
Single Arm - Previous HF Hospitalization Only (Pre-COVID-19)
1.853
Single Arm - Elevated NT-proBNP/BNP Only (During COVID-19)
0.391
Single Arm - Previous HF Hospitalization Only (During COVID-19)
0.698
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]Primary· 12 Months Post Implantation
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
3. The number of deaths of any cause
added together with equal weighting into a total number of events
Group
Value
95% CI
Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related Events]
0.381
Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related Events]
0.746
Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related or Possibly Related Events]
0.377
Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related or Possibly Related Events]
0.737
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic VisitsSecondary· 12 months post-implantation
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy
added together with equal weighting into a total number of events
Group
Value
95% CI
Randomized Arm - Treatment Group
0.474
Randomized Arm - Control Group
0.557
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)Secondary· The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy
added together with equal weighting into a total number of events
Group
Value
95% CI
Randomized Arm - Treatment Group [Pre-COVID-19]
0.450
Randomized Arm - Control Group [Pre-COVID-19]
0.595
Randomized Arm - Treatment Group [During COVID-19]
0.539
Randomized Arm - Control Group [During COVID-19]
0.455
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)Secondary· 12 Months Post Implantation
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy
added together with equal weighting into a total number of events
Group
Value
95% CI
Randomized Arm - Treatment Group (Pre-COVID-19)
0.529
Randomized Arm - Control Group (Pre-COVID-19)
0.729
Randomized Arm - Treatment Group (During COVID-19)
0.465
Randomized Arm - Control Arm (During COVID-19)
0.488
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)Secondary· 12 Months Post Implantation
The composite outcome of:
1. The number of recurrent heart failure hospitalizations (HFHs)
2. The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy
added together with equal weighting into a total number of events
Group
Value
95% CI
Randomized Arm - Treatment Group [Excluding COVID-19 Related Events]
0.474
Randomized Arm - Control Group [Excluding COVID-19 Related Events]
0.551
Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events]
0.472
Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events]
0.545
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse device effects (ADEs), serious adverse device effects (SADEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) were summarized for subjects enrolled in this trial as number of events, the number and percentage of subjects with events and event rate as number of events/subject-month. Adverse event data were collected during the 1-year follow-up period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03387813.