The objective of this clinical investigation is to assess and characterize the clinical management of HeartMate 3 LVAD patients guided by hemodynamic parameters provided by the CardioMEMS HF System as a clinical hybrid construction to optimize…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate the feasibility of using hemodynamic guidance by the PA sensor
in LVAD HM-III patients.
Secondary outcome
- 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
Background summary
Advanced heart failure and LVAD treatment is complex and associated with
strongly elevated risk of postoperative complications as well as high rates of
re-hospitalizations. Currently, the LVAD pump only provides basic data and
clear hemodynamic feedback is lacking. There is a strong clinical demand for
guidance of therapy in these patients. Hemodynamic guidance may improve the
pre-operative phase by delivering the patient in a more optimal condition to
surgery. Also, it may improve peri- and postoperative fluid management and
detect complications in an earlier stage. Hemodynamic feedback is now possible
with the CardioMEMS sensor, even at home.
Study objective
The objective of this clinical investigation is to assess and characterize the
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.
Study design
The current study is a prospective single-centre observational 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.
Study burden and risks
The implantation of the CardioMEMS sensor is a relatively small procedure with
risk comparable to the regular right heart catheterization (occurring in all
patients). The main burden of the CardioMEMS sensor is the femoral venous
puncture with associated bleeding complications at entry site. Patient must
tolerate a routine Swan Ganz measurement (right heart catheterization), which
will be a procedure of 30 minutes and comply with the daily pressure recordings
of 18 seconds. The out-patient clinic follow-up scheme is comparable to
standard care. The device has been shown to be reliable and safe in the
CHAMPION trial with 1.4% complication rate which were all minor and manageable.
The risk-to-benefit ratio is extremely low as reported in the CHAMPION trial
with a reduction in HF hospitalizations by about 40% with virtually no major
device related complications. The device has been approved by FDA and is CE
marked and clinically available.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL61544.078.17 |