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. 2023 Sep 26;12(19):6200. doi: 10.3390/jcm12196200

Table 1.

Overview of key clinical trials in implantable device-based RM.

Device Study Patient Population Data Collection and Storage Frequency of Data Monitoring and Data Management Outcome
Implantable pulmonary artery pressure monitoring devices
CardioMEMS CHAMPION
(2007–2010)		 550 patients with NYHA class III HF across 64 sites in the U.S.
  • -

    CardioMEMS pillow collected data/portable electronic unit

  • -

    Data transmitted to secure Internet-based database for physician review
  • -

    Recorded PAP daily

  • -

    Prespecified guidelines based on PAP measurements
  • -

    Reduction in HFH but not all-cause mortality at 6 months
Postapproval study
(2014–2017)		 1200 patients with NYHA class III HF and prior HFH within 12 months across 104 sites in the U.S.
  • -

    Recorded PAP daily

  • -

    Prespecified guidelines based on PAP measurements
  • -

    Reduction in HFH at 12 months
GUIDE-HF
(2018–2022)		 1000 patients with NYHA class II–IV HF and prior HFH within 12 months or elevated BNP across 118 sites in the U.S. and Canada
  • -

    Recorded PAP daily

  • -

    Specific interventions at discretion of treating provider but aimed to achieve PAP goal ranges as in CHAMPION trial
  • -

    Reduction in primary endpoint of HFH/urgent visits and all-cause mortality at 12 months
MEMS-HF
(2016–2020)		 234 patients with NYHA class III HF across 31 sites in Europe
  • -

    Recorded PAP daily

  • -

    Reviewed at least weekly or sooner if automatic alert triggered
  • -

    Freedom from device- or system-related complications and from sensor failure at 12 months

  • -

    Reduction in HFH at 12 months
MONITOR-HF
(2019–2022)		 348 patients with NYHA III and prior HFH across 25 sites in the Netherlands
  • -

    Record PAP daily

  • -

    Prespecified guidelines based on evidence of excess intravascular volume or resistance
  • -

    Freedom from device- or system-related complications and from sensor failure at 12 months

  • -

    Improvement in quality of life (by Kansas City Cardiomyopathy Questionnaire) and reduction in HFH at 12 months
Cordella endotronix SIRONA
(2017–2019)		 15 patients with NYHA class III HF in Europe
  • -

    Combined with a Wireless handheld reader (myCordella Patient Reader) and tablet, which collect and transmit data to a web-based Patient Management Portal (secure cloud-based platform) for review by clinical team
  • -

    Recorded PAP daily in addition to vital signs
  • -

    No device- or system-related complications or sensor failure

  • -

    Met primary efficacy endpoint of mean PAP at 90 days
SIRONA II
(2019–2021)		 81 patients with NYHA class III HF in Europe
  • -

    Met primary efficacy endpoint of accuracy, comparing the PA sensor mean PAP measurements with RHC PAP measurements

  • -

    Minimal device- or system-related complications

  • -

    No sensor failure
PROACTIVE-HF
(2020-estimated 9/2023)		 456 patients with NYHA class III HF currently enrolled across 79 sites in the U.S. and Europe
  • -

    Recorded PAP daily in addition to vital signs and symptoms

  • -

    Reviewed at least once every 4 days

  • -

    The 7-day mean PAP along with other data used to make guideline-based decisions
  • -

    Ongoing, estimated study completion March 2026

  • -

    Freedom from device-/system-related complication and from pressure sensor failure

  • -

    HFH or all-cause mortality at 6 months
Implantable left atrial pressure monitoring devices
Vectorius V-LAP VECTOR-HF
(2019-estimated 12/2023)		 24 patients with NYHA class III HF across two sites in Europe
  • -

    Combined with an external reader that transmits data to a secured Cloud Storage database
  • -

    Recorded LAP daily

  • -

    Alerts triggered to patient and provider when LAP is out of optimal range
  • -

    Ongoing trial

  • -

    Data to date suggest agreeability with wedge-pressure measurements and effectiveness in improving NYHA functional class status
Implantable inferior vena cava monitoring devices
FIRE1 FUTURE-HF (NCT04203576)
(2019-estimated 8/2023)		 Goal enrollment of 50 patients with HF and prior HFH within 6 months across 10 sites in Europe
  • -

    Combined with an external detection belt that transmits data for review by clinical team
  • -

    Recorded IVC dimensions daily
  • -

    Ongoing trial

  • -

    Primary safety endpoint is procedural success and freedom from FIRE1 sensor complications at 3 months

  • -

    Primary technical endpoint is signal acquisition at 3 months
Implantable cardiac monitors
LUX-Dx ICM TRENDS (NCT04790344)
(2021-estimated 5/2026)		 Goal enrollment of 525 patients with NYHA class II–III HF across 74 sites in the U.S.
  • -

    Combined with a patient app that transmits data to the Latitude Clarity Data Management System for review by clinical team
  • -

    Loop recorder that records heart rhythms 24/7
  • -

    Ongoing trial

  • -

    Primary outcome of comparing diagnostic sensor data with reference clinical testing data and heart failure decompensation events
Reveal LINQ ICM ALLEVIATE-HF (NCT04452149)
(2020-estimated 11/2024)		 Goal enrollment of 700 patients with NYHA class II–III across 59 sites in the U.S.
  • -

    Combined with a transmitter or smartphone app that downloads and transmits data securely for review by clinical team
  • -

    Loop recorder that records heart rhythms 24/7

  • -

    Diagnostic-based risk stratification algorithm
  • -

    Ongoing trial

  • -

    Primary outcomes of safety and efficacy of a patient management pathway

BNP, brain natriuretic peptide; HF, heart failure; HFH, heart failure hospitalization; ICM, implantable cardiac monitors; IVC, inferior vena cava. LAP, left atrial pressure; NYHA, New York Heart Association; PAP, pulmonary artery pressure; RM, remote monitoring; U.S., United States.