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Completed

NCT Number: NCT03247829

Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Health, La Jolla, California, United States

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About this study

The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:

  • Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
  • Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
  • Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
  • Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
  • No connectivity or transmission problems with CardioMEMS
  • On HeartMate LVAD support for at least 3 months
  • Age ≥ 18 years

Exclusion criteria

  • Current participation in an investigation that is likely to confound study results or affect study outcome
  • Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
  • Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)

Treatment and study plan

Hemodynamic management using CardioMEMS HF System

Device

Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges

Primary outcomes

  1. Six Minute Hall Walk (6MHW) Distance

    Time frame: Six Months

    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.

Other outcomes

  1. Change in PA Diastolic Pressure From Baseline to 6 Months

    Time frame: six months

    Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up.

  2. Days PA Diastolic Pressure is in the Pre-specified Target Range

    Time frame: six months

    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.

  3. PA Diastolic Pressure Before 6MHW Test to After 6MHW Test

    Time frame: 6 months

    Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test.

  4. Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions

    Time frame: six months

    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.

  5. New York Heart Association (NYHA) Classification

    Time frame: six months

    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.

  6. EQ-5D-5L VAS

    Time frame: six 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.

  7. Number and Percent of Participants With All-cause Hospitalizations.

    Time frame: six months

    Number and percent of participants who were hospitalized for any cause during follow-up.

  8. Number and Percent of Participants With Worsening Heart Failure Events

    Time frame: six months

    Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure

Acronym: INTELLECT 2-HF

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2017
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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