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HEMOdynamic guidance with CardioMEMS in LVAD patients


- candidate number28161
- NTR NumberNTR6804
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2017
- Secondary IDsMETC 2017-342 
- Public TitleHEMOdynamic guidance with CardioMEMS in LVAD patients
- Scientific TitleHEMOdynamic guidance with PA-sensor CardioMEMS in patients with an left ventricular assist device (VAD)
- ACRONYMThe HEMO-VAD study
- hypothesis1. testing the feasibility of the use of an hybrid construction of a CardioMEMS PA sensor and HeartMate III LVAD therapy (with permission of the company Abbott).
2. Hemodynamic guidance improves patient outcome and HF hospitalizations by early detection of complications
- Healt Condition(s) or Problem(s) studiedLeft Ventricular Assist Device (LVAD)
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Signed Informed Consent Form (ICF)
• Age ≥18 years
• LVEF <25%
• NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV with INTERMACS classes 2-5
• Scheduled or intended for LVAD implantation within 2 weeks
• Body surface Area >= 1.2 m2 and chest circumference, at the axillary level, of less than 65 inches if BMI >35 kg/m2
• Females of child bearing age must agree to use adequate contraception and at inclusion negative pregnancy test
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:

• No written informed consent
• patients with contra-indications for the PA pressure sensor device, which will include active infection, a history of deep vein thrombosis or recurrent pulmonary embolism,
• unable to tolerate right heart catheterization
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients’ health status
• patients with a known coagulation disorder or hypersensitivity to aspirin.
• History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (>1 episode) pulmonary embolism and/or deep vein thrombosis
• Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention (which makes CardioMEMS sensor no additive value)
• History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
• Serum creatinine ≥ 221 umol/L or eGFR below 25 or the need for chronic renal replacement therapy
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
• patients with mechanical right heart valves,
• INTERMACS 1 emergency LVAD implantations.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2017
- planned closingdate1-aug-2018
- Target number of participants10
- InterventionsHemodynamic guidance by CardioMEMS PA sensor
- Primary outcomeTo investigate the effectiveness and potential of the hybrid construction between CardioMEMS PA senseor and HeartMate-III LVAD device

The number of HF hospitalizations
- Secondary outcomePost-hoc analyses will be performed to study pulmonary hypertension and its potential reversibility during LVAD treatment. Additionally, we will study heart rate detection with cardioMEMS during LVAD treatment and the incidence of VTs. Additionally, we will study renal function and urinary measurements during follow-up with LVAD treatment in relation to PA pressure, and Rv function.
- Timepointsfollow-up of 1 year
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.J. Brugts
- CONTACT for SCIENTIFIC QUERIESDr. J.J. Brugts
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
St Jude Abbott
- Publications-
- Brief summaryThe HEMO-VAD study will assess clinical management of HeartMate 3 LVAD patients guided by hemodynamic parameters provided by the CardioMEMS HF System as a clinical hybrid construction to optimize patient outcome and reduce HF hospitalizations and complications of LVAD therapy. The current study is a prospective single-centre observational pilot study investigating the feasibility of hemodynamic guidance by CardioMEMS in LVAD care. Data will be collected on functional status, health care utilization and clinical (safety) outcomes. The study population for this clinical investigation is advanced HF NYHA class III patients with dyspnea upon mild physical activity, or NYHA class IV patients who are refractory to advanced HF management and scheduled for semi-elective or elective LVAD implantation (INTERMACS class 2-5).
- Main changes (audit trail)
- RECORD8-nov-2017 - 25-nov-2017


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