se of Pre- and Intensified Post-Procedural Physiotherapy in Patients with Symptomatic Aortic Stenosis undergoing Transcatheter Aortic Valve Replacement

Not Applicable

Suspended

• Conditions: I35.0; Aortic (valve) stenosis

• Registration Number: DRKS00017239
• Lead Sponsor: Herzzentrum der Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 260

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

• 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AC Mortality and rehospitalisation 90 days after TAVR

Secondary Outcome Measures

Name	Time	Method
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.