To assess procedural hemodynamic indices of paravalvular leakage and to relate these to cardiac MRI at 1 month and clinical follow-up over 5 years.To diagnose angiodysplasia en determine the effect of TAVI on these angiodysplastic lesions.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Gastrointestinal vascular conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as PVL regurgitation fraction as measured by
cardiac MRI.
Secondary outcome
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.
Background summary
During a TAVI, a new heart valve is placed in the native (calcified) heart
valve. Hereby the old valve blades are pushed aside by the new valve. It is
possible that the edges of the new heart valve do not fit nicely with the edges
of the native valve. This can cause leakage from the aorta (the large body
artery) to the left heart chamber. It is known that a serious leakage can have
a negative influence on the prognosis in the longer term. When an important
leak is seen, the placed valve can be pressed with a balloon so that it better
fits the surrounding tissue and the leak can be reduced.
The extent of PVL is currently determined during a TAVI by echocardiography.
However, it has been found that this often underestimates the extent of PVL and
is poorly reproducible. With a MRI (Magnetic Resonance Imaging) scan the amount
of PVL can be determined in a reliable and reproducible manner. However, making
an MRI scan takes some time, which means that echocardiography remains the
standard during TAVI.
During the TAVI procedure, standard pressures in the heart and the large body
artery (aorta) are also measured. With these pressures, particular attention is
paid to the pressures needed for the left heart chamber to get the blood into
the aorta. However, there are also indications that the degree of PVL could be
derived from these pressures. To be able to investigate this, the blood
pressure measurements will be compared to the amount of PVL as measured by
means of MRI.
In patients with severe aortic stenosis, anemia is common. The anemia is most
frequently caused by angiodysplasia. Angiodysplasia are vascular anomalies in
the gastrointestinal tract, which tend to bleed easily. This can lead to blood
loss from the gastrointestinal tract, which can cause anemia. Symptoms can be
paleness and tiredness. In case of coexistence of angiodysplasia and aortic
stenosis, this is called Heyde syndrome.
Little is known about Heyde syndrome. Therefore, it is still unknown what the
best treatment is. Previous studies showed a beneficial effect of the TAVI
procedure on angiodysplasia. However, the duration of this beneficial effect is
unknown. To enhance our knowledge about Heyde syndrome, we want to perform a
videocapsule endoscopy (VCE). This capsule moves throughout the
gastrointestinal tract and visualises the mucosal layer. The VCE will be
excreted by the body in a natural way.
Study objective
To assess procedural hemodynamic indices of paravalvular leakage and to relate
these to cardiac MRI at 1 month and clinical follow-up over 5 years.
To diagnose angiodysplasia en determine the effect of TAVI on these
angiodysplastic lesions.
Study design
This is a prospective, single center clinical trial. Patients will receive a
TAVI. After implantation different hemodynamic indices of PVL will be assessed.
Within 4-8 weeks after TAVI, a cardiac MRI will be performed to quantify the
amount of PVL. Standardized clinical follow-up will take place at discharge, 30
days, 3 months, 6 months and yearly up to 5 years.
The 3- and 6-months visits will only consist of lab analysis.
Patients participating in the substudy 'Heyde syndrome' will undergo a
videocapsule endoscopy (VCE) in the period before TAVI.
The VCE will be repeated 6 months after TAVI.
Study burden and risks
The hemodynamic indices can be assessed in a standard fashion using a fluid
filled pigtail catheter that is placed in the left ventricle as part of the
routine protocol. Following TAVI, enrolled patients will undergo cardiac MRI to
assess PVL. The risk of cardiac MRI after TAVI implantation is negligible.
Extra blood samples will be taken. After one year, patients will be followed by
telephonic follow- up. Risk/benefit: The expected benefit is a structured
clinical follow-up at 1,2,3,4 and 5 years, at the cost of an extra visit to
undergo cardiac MRI.
Videocapule endoscopy (VCE) is a frequently performed diagnostic procedure. The
risk of complications is low. This is described in detail in the 'PIF'.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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 <0.25 or an initial aortic valve area (AVA) of <=
1.0cm² (indexed EOA<=06cm²/m²) as measured by trans thoracic echocardiography
<6months prior to inclusion
4. Patients have symptomatic aortic stenosis, as demonstrated by NYHA
functional class 2 or greater or other symptoms of aortic stenosis (e.g.
syncope or angina in the absence of coronary artery disease).
5. Surgical risk is deemed high or intermediate by STS score or by documented
Heart-team agreement due to frailty or co-morbidities.
6. The aortic annulus diameter as measured by ECG-triggered CT-scanning <
6months prior to inclusion meets the ranges indicated in the instructions for
use
7. The access artery diameters (femoral or subclavian) as measured by
CT-scanning < 6 months prior to inclusion meet the ranges indicated in the
instruction for use
8. There are no contra-indications for and patient is willing to undergo
cardiac MRI at discharge to 30 days after TAVI.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70413.091.19 |