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ID
Source
Brief title
Health condition
The study population for this clinical investigation (pilot feasibility study) is advanced heart failure NYHA class III patients with dyspnea upon mild physical activity, or NYHA class IV patients who are refractory to advanced heart failure management and scheduled for semi-elective or elective LVAD implantation (INTERMACS class 2-5).
The CardioMEMS device has been studied in chronic heart failure patients but not in LVAD patients. With permission of the company, we study this new patient groups. The sensor is impanted in patient with chronic heart failure before LVAD implantation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the effectiveness and potential of the hybrid construction between CardioMEMS PA senseor and HeartMate-III LVAD device
The number of HF hospitalizations
Secondary outcome
Post-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.
Background summary
The 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).
Study objective
1. 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
Study design
follow-up of 1 year
Intervention
Hemodynamic guidance by CardioMEMS PA sensor
J.J. Brugts
s gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31614229373
j.brugts@erasmusmc.nl
J.J. Brugts
s gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31614229373
j.brugts@erasmusmc.nl
Inclusion criteria
In 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 criteria
A 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6627 |
| NTR-old | NTR6804 |
| Other | : METC 2017-342 |