Objective: 1. Investigate the prevalence of ATTR in patients undergoing TAVR in the Netherlands.2. To determine whether ATTR influences the effectiveness of TAVR treatment on LV dysfunction.
ID
Source
Brief title
Condition
- Other condition
- Cardiac valve disorders
Synonym
Health condition
Tevens aandoeningen van hey myocard (amyloidoseophoping).
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
1. Prevalence of ATTR, measured by bone scintigraphy, in patients undergoing
TAVR.
2. Differences in acute hemodynamic response to TAVR between ATTR and non-ATTR
patients.
Secondary outcome
1. To determine the influence (relative contribution) of ATTR to the LV
dysfunction in patients with AS undergoing TAVR.
2. To determine whether ATTR influences the effectiveness of TAVR treatment on
improvement in Quality of Life.
3. To determine whether ATTR influences survival and future hospitalizations
rate after TAVR treatment
4. To determine possible predictors of the presence of ATTR, using
echocardiography and biomarkers.
Background summary
Rationale: Transcatheter aortic valve replacement (TAVR) is currently the
treatment of choice in patients with severe aortic valve stenosis (AS).
However, not all patients benefit equally from a TAVR. Amyloidosis might be
comorbidity which may impact outcome unfavorably. Amyloidosis is known to cause
left ventricular (LV) dysfunction and might additionally contribute to symptoms
which might not be resolved by TAVR. In the United States of America 16% of
TAVR patients were reported to have concomitant transthyretin amyloidosis
(ATTR). The prevalence of ATTR in TAVR patients in the Netherlands is unknown
as well as its relation with quality of life and outcome.
Study objective
Objective:
1. Investigate the prevalence of ATTR in patients undergoing TAVR in the
Netherlands.
2. To determine whether ATTR influences the effectiveness of TAVR treatment on
LV dysfunction.
Study design
Study design: Single center, prospective, observational study.
Study burden and risks
In bone scintigraphy the tracer 99mTc-HPD ([technetium-99m] -
[3,3-diphosphono-1,2-propanodicarboxylic acid]) is used. It is a minimally
invasive procedure, as only the tracer needs to be administered intravenously.
A small possibility of an allergic reaction to the tracer is possible. The
expected radiation dose from the entire procedure is 4.5 mSv per scan. There is
no risk for other people that come in contact with the patient after the scan.
The invasive hemodynamic measurements will be obtained with a pressure-volume
loop catheter during the TAVR procedure. For this measurement a catheter will
be placed in the left ventricle and an extra venous acces sheath will be
inserted. These procedures bear minimal additional risk to the patiënts on top
op the risk of TAVR procedure.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Severe symptomatic aortic valve stenosis
Exclusion criteria
- Unable to undergo scintigraphy
Design
Recruitment
Medical products/devices used
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 | NL70998.042.19 |