NL-OMON46145
Completed
Not Applicable
HEMOdynamic guidance with PA-sensor CardioMEMS in patients with an left ventricular assist device (LVAD) - HEMO-VAD pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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 1 month
- •\-Body surface Area \>\<\= 1\.2 m2 and chest circumference, at the axillary level, of less than 65 inches if BMI \>35 kg/m2
Exclusion Criteria
- •\*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,
- •\*Patients unable to tolerate right heart catheterization
- •\*Intolerance to anticoagulant or antiplatelet therapies
- •\*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 LVAD management
Outcomes
Primary Outcomes
Not specified
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