Adjustment following implantation of a left ventricular assist device in patients with CHF, and their partners; a prospective, multi-center observational study (ADJUST-LVAD)
- Conditions
- heart failure10019280
- Registration Number
- NL-OMON34122
- Lead Sponsor
- niversiteit van Tilburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Patients: implantation with an axial-flow Heartmate II (Thoratec) left ventricular assist device, aged >=18 years, sufficiently proficient in the Dutch language to be able to complete the study questionnaires, and providing written informed consent.
Partners: study participation of the LVAD patient, aged >=18 years, sufficiently proficient in the Dutch language to be able to complete the study questionnaires, and providing written informed consent.
Patients: implantation with an LVAD other than the axial-flow Heartmate II (Thoratec), <18 years of age, history of psychiatric illness other than cognitive-affective disorder, insufficient knowledge of the Dutch language.
Partners: no study participation of LVAD patient, <18 years of age, history of psychiatric illness other than cognitive-affective disorder, life expectancy less than 1 year, insufficient knowledge of the Dutch language.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary: Health status; distress (anxiety/depressive symptoms). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: Morbidity (i.e., complications (defined as infection, bleeding,<br /><br>neurologic dysfunction, and device malfunction) and rehospitalization);<br /><br>mortality (both cardiac and non-cardiac); heart transplantation.</p><br>