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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025003

Enrollment

Registered

2021-08-11

Start date

2021-07-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G72 I35.0

Interventions

Group 1: Patients with high-grade aortic valve stenosis who receive TAVI are measured before valve implantation and afterwards

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

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

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.)

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactBastian Schrader

Universitätsklinik für Kardiologie, Klinikum Oldenburg

bastian.schrader@uni-oldenburg.de0441 403 77142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026