I35.0
Conditions
Interventions
Group 1: The control group received only postoperative physiotherapy for 1 x 30 minutes per day until discharge
Group 2: The intervention group (IMT-group) received individualized physiotherapy exerci
Sponsors
Herzzentrum der Universität Bonn
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subject must have co-morbidities such that one cardiologist and one cardiac surgeon agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. • Subject has senile degenerative aortic valve stenosis with: mean gradient > 40 mmHg or jet velocity greater than 4.0 m/s by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of = 0.8 cm2 (or aortic valve area index = 0.5 cm2/m2) by resting echocardiogram. • Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class Class III or greater. If screening committee agrees the eligibility of a patient with class II , based on medical factors, he/she can be enrolled. • Patient has been informed of the nature of the trial and has signed an Informed Consent Form. • Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.
Exclusion criteria
Exclusion criteria: • Immobilisation in wheelchair • Bedridden patients • Major depressive disorder • Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). • Pregnancy • Blood dyscrasias as defined: Leukopenia (WBC count < 1,000 cells/mm3) Thrombocytopenia (platelet count <50,000 cells/mm3) • Untreated clinically significant coronary artery disease requiring revascularization. • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. • Need for emergency surgery for any reason. • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack(TIA). • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin, Thienopyridine, Heparin, Contrast media, Nitinol (titanium and nickel alloy) • Ongoing sepsis, including active endocarditis. • Life expectancy < 12 months due to associated non-cardiac co-morbid conditions. • Currently participating in an investigational drug or another device trial. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. • Symptomatic carotid or vertebral artery disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AC Mortality and rehospitalisation 90 days after TAVR | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include the occurrence of individual major adverse cardiovascular and cerebrovascular event (MACCE) components, incidence of pneumonia, cardiovascular-mortality, and/or cardiovascular re–hospitalization at 30 days and 3 months following TAVR. | — |
Countries
Germany
Contacts
Public ContactMarcel Weber
Herzzentrum der Universität Bonn
Outcome results
None listed