Assessment of paravalvular leak after transcatheter aortic valve implantation by hemodynamic measurements and cardiac MRI

Assessment of paravalvular leak after transcatheter aortic valve implantation by hemodynamic measurements and cardiac MRI - Appose trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50145

Enrollment

Registered

2019-09-25

Start date

2019-10-02

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Aortic Valve Stenosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients must be >18 years old. 2. Written informed consent is obtained from all patients. 3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s or Doppler Velocity index

Exclusion criteria

Exclusion criteria: 1. Patient is unwilling or unable to comply with study-required follow-up evaluations 2. There is evidence of a myocardial infarction within 30 days to index procedure 3. The presence of severe mitral regurgitation or stenosis 4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic ring in any position 5. Left ventricular ejection fraction (LVEF) less than 30% 6. Untreated significant coronary artery disease requiring revascularization 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation suggesting active endocarditis 8. The patient is hemodynamically unstable, requiring inotropic or vasopressive and / or mechanical support 9. The presence of pulmonary edema or intra venous diuretics to stabilize heart failure at index procedure 10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or end-stage renal disease requiring dialysis 11. Morbid obesity, defined as a BMI >=40 12. A life expectancy of less than one year.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is defined as PVL regurgitation fraction as measured by cardiac MRI.	—

Secondary

Measure	Time frame
The secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)(1) and will comprise death, vascular complications, stroke/ TIA, life threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis. Other secondary endpoint is the effect of TAVI on angiodysplasia. The effect is expressed in difference between hemoglobin level before TAVI and 6 months after TAVI. The difference between blood transfusion and/or iron infusion requirements before and 6 months after TAVI will also be determined.	—

Measure

Time frame

The secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)(1) and will comprise death, vascular complications, stroke/ TIA, life threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis. Other secondary endpoint is the effect of TAVI on angiodysplasia. The effect is expressed in difference between hemoglobin level before TAVI and 6 months after TAVI. The difference between blood transfusion and/or iron infusion requirements before and 6 months after TAVI will also be determined.

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Countries

Netherlands

Outcome results