Adjustment following implantation of a left ventricular assist device in patients with CHF, and their partners; a prospective, multi-center observational study (ADJUST-LVAD)

Adjustment following implantation of a left ventricular assist device in patients with CHF, and their partners; a prospective, multi-center observational study (ADJUST-LVAD) - ADJUST-LVAD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34122

Enrollment

130

Registered

2010-12-02

Start date

2011-01-03

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Patients: implantation with an LVAD other than the axial-flow Heartmate II (Thoratec),

Design outcomes

Primary

Measure	Time frame
Primary: Health status; distress (anxiety/depressive symptoms).	—

Secondary

Measure	Time frame
Secondary: Morbidity (i.e., complications (defined as infection, bleeding, neurologic dysfunction, and device malfunction) and rehospitalization); mortality (both cardiac and non-cardiac); heart transplantation.	—

Countries

Netherlands

Outcome results