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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46145

Enrollment

Registered

2017-07-27

Start date

2017-11-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endstage heartfailure LVAD implantation

Interventions

LVAD

CardioMEMS

Hemodynamic monitoring

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: -Signed Informed Consent Form (ICF) -Age *18 years -LVEF 35 kg/m2

Exclusion criteria

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.

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

Measure	Time frame
To demonstrate the feasibility of using hemodynamic guidance by the PA sensor in LVAD HM-III patients.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)