Improved hemodynamics after aortic valve implantation promotes skeletal muscle neuromuscular function through a cardiac/spinal cord/skeletal muscle axis

Not Applicable

Recruiting

Conditions: G72
I35.0
Other myopathies
Aortic (valve) stenosis

Registration Number: DRKS00025003

Lead Sponsor: niversitätsklinik für Kardiologie, Klinikum Oldenburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

People of any gender and age with high-grade aortic valve stenosis and indication for TF-TAVI.
- The diagnosis of aortic valve stenosis must have been confirmed by TAVI screening
- Therapeutic indication for TF-TAVI in the independent heart team visit (consisting of senior physicians of cardiology, cardiac surgery and anesthesiology)
- Signed informed consent must be available before the start of the survey

Exclusion Criteria

- No confirmed high-grade aortic valve stenosis (low/moderate aortic valve stenosis)
- Other forms of therapeutic intervention e.g. transapical TAVI or open aortic valve replacement
- No medical indication for TAVI
- Immobility e.g. due to leg amputations
- Neuromuscular diseases: Stroke, polyneuropathies (diabetic), multiple sclerosis.
- Lack of informed consent
- Severe disease of the peripheral blood vessels (pAVK, vasculitis, etc.)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. change in the discharge rate of motor units after TF-TAVI.<br>2. change of the discharge variability<br>3. change of beta oscillations of motor neurons<br>4. change in the threshold of motor unit discharge characteristics<br>5. change of muscle force in EMG<br>6. change of fatigability of the M.tibialis anterior

Secondary Outcome Measures

Name	Time	Method
1. change of heart rate variability after TF-TAVI<br>2. change of walking distance in the 6-minute walking test after TF-TAVI<br>3. change in inflammation levels (IL-2, IL-6, semaphorin-3F) after TF-TAVI<br>4. change in all-cause mortality and cardiovascular mortality at 6 months after TF-TAVI<br>5. change in morbidity (hospitalizations, new-onset cardiac disease) after TF-TAVI<br>6. change in quality of life CASP-12 and Minnesota Living With Heart Failure Questionnaire (MLWHFQ) score after TF-TAVI.