I35.0
Conditions
Interventions
Group 1: Patients who, after successful TAVI, receive a paper printout of the initial aortic valve findings and the final intervention results with a layman's explanation of the success of the therapy
Sponsors
Kerckhoff Klinik GmbH, Herzzentrum - Abteilung für Kardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Symptomatic, severe aortic valve stenosis with indication for TAVI according to current guidelines (ESC, DGK) and in accordance with Heart Team consensus ? Willingness to participate voluntarily with a signed study informed consent form
Exclusion criteria
Exclusion criteria: ? Known pregnancy at the time of inclusion ? EF < 35% ? Severe, uncontrolled lung disease ? Impaired vision ? Impaired hearing ? Medications that affect the opioid system ? Concomitant high-grade valve defect ? Concomitant relevant coronary heart disease ? Hb = 7 g/dl ? Participation in another interventional clinical trial ? Life expectancy < 1 year due to a non-cardiac disease ? Cardiac amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the change in KCCQ and TASQ-derived QoL scores from baseline to discharge and 3 months after TAVI in order to perform valid case number planning for a larger study. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change in dyspnea according to NYHA from baseline to discharge and 3 months after TAVI ? Change in angina pectoris according to CCS and SAQ from baseline to discharge and 3 months after TAVI ? Value of structured questionnaires (MoCA, MMST) for detecting even mild cognitive impairment and its effect on QoL and symptoms ? Prevalence of delirium after TAVI and its prediction by mild cognitive impairment according to MoCA and MMST ? Effect of frailty on QoL and symptoms after TAVI ? Effect of pessimistic/optimistic attitude according to LOT-R on QoL and symptoms after TAVI ? QoL and symptoms from baseline to discharge and 3 months after TAVI in normal-flow high-gradient AS ? QoL and symptoms from baseline to discharge and 3 months after TAVI in “classic” (with low systolic left ventricular function) low-flow low-gradient AS ? QoL and symptoms from baseline to discharge and 3 months after TAVI in “paradoxical” (with preserved systolic left ventricular function) low-flow low-gradient AS intervention | — |
Countries
Germany
Contacts
Public ContactMatthias Renker
Kerckhoff Klinik GmbH
Outcome results
None listed