Effects of Percutaneous Aortic Valve Implantation on Left Ventricular Function And Coronary Hemodynamics

Effects of Percutaneous Aortic Valve Implantation on Left Ventricular Function And Coronary Hemodynamics - Effects of PAVI on LVF and coronary hemodynamics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33340

Enrollment

120

Registered

2009-09-16

Start date

2009-06-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

aortic valve narrowing aortic valve stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Severe symptomatic native aortic valve stenosis - Percutaneous or surgical aortic valve replacement (with biological valve prosthesis) - Age above 75 years with one or more surgical risk factors

Exclusion criteria

Exclusion criteria: - Previous aortic valve replacement - Surgical aortic valve replacement combined with CABG or other valve surgery - Severe left ventricular dysfunction - Severe infection - Recent myocardial infarction or stroke - Enrolled in another investigational study

Design outcomes

Primary

Measure	Time frame
The short and long term change in left ventricular function after (percutaneous) aortic valve implantation, measured invasively by means of PV-loops and non-invasively with echocardiography and cardiac CT and MRI.	—

Secondary

Measure	Time frame
The secondary study parameters compared with baseline and, where possible, compared between the PAVI and SAVR are: invasively measured LV systolic and diastolic properties, coronary flow characteristics, LV ejection fraction, LV mass, LV myocardial perfusion, flow properties across the aortic valve, presence/amount of aortic and mitral regurgitation, right ventricular function, cardiac conduction, microcirculation, mortality and morbidity, NYHA functional class and quality of life, Von Willebrand factor activity and blood levels of NT-pro-BNP and other markers of heart failure.	—

Measure

Time frame

The secondary study parameters compared with baseline and, where possible, compared between the PAVI and SAVR are: invasively measured LV systolic and diastolic properties, coronary flow characteristics, LV ejection fraction, LV mass, LV myocardial perfusion, flow properties across the aortic valve, presence/amount of aortic and mitral regurgitation, right ventricular function, cardiac conduction, microcirculation, mortality and morbidity, NYHA functional class and quality of life, Von Willebrand factor activity and blood levels of NT-pro-BNP and other markers of heart failure.

—

Countries

Netherlands

Outcome results