HEMOdynamic guidance with PA-sensor CardioMEMS in patients with an left ventricular assist device (LVAD)

Completed

• Conditions: endstage heartfailure; LVAD implantation; 10019280

• Registration Number: NL-OMON46145
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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
*Patients with mechanical right heart valves,
*INTERMACS 1 emergency LVAD implantations.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate the feasibility of using hemodynamic guidance by the PA sensor<br /><br>in LVAD HM-III patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- investigate whether the use of CardioMEMS PA sensor in HeartMate-III LVAD<br /><br>patients improves outcome, reduce complications and reduce HF hospitalizations<br /><br>- to study detected hemodynamic effects in case of LVAD associated<br /><br>complications such as RV failure, pump thrombosis, gastro-intestinal bleeding<br /><br>or pump infection<br /><br>- to study the reversibility of pulmonary pressures and pulmonary hypertension<br /><br>during LVAD therapy </p><br>