Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™ (INTELLECT 2-HF)

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: Hemodynamic management using CardioMEMS HF System

Study type: Observational

Funder types: Industry

Identifiers

NCT03247829

SJM-CIP-10178

Details and patient eligibility

About

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

Full description

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

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
2. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
3. No connectivity or transmission problems with CardioMEMS
4. On HeartMate LVAD support for at least 3 months
5. Age ≥ 18 years

Exclusion criteria

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

Trial design

101 participants in 2 patient groups

Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment

Description:

Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System

Treatment:

Device: Hemodynamic management using CardioMEMS HF System

Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment

Description:

Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System

Treatment:

Device: Hemodynamic management using CardioMEMS HF System