The main objective is to assess the effects of TAVI on cardiac sympathetic activity.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change of cardiac sympathetic activity after aorta valve replacement.
Secondary outcome
This does not apply
Background summary
The precise effects of percutaneous aortic valve implantation (TAVI) on left
ventricular function (LVF) and cardiac sympathetic activity have not been
clarified yet. In the literature an observation has been described that the LVF
improves after TAVI and after surgical aortic valve replacement (SAVR). This
has been evaluated by echocardiography. The change of cardiac sympathetic
activity assessed by 123I-MIBG scintigraphy has not been described before. This
study is conducted as an observational study in which the effects on cardiac
sympathetic activity after TAVI will be compared to the effects on cardiac
sympathetic activity after SAVR. Our hypothesis is that by reducing the aortic
pressure gradient after TAVI, the left ventricular dynamics will improve
immediately after the procedure and will result in change of LVF and cardiac
sympathetic activity.
Study objective
The main objective is to assess the effects of TAVI on cardiac sympathetic
activity.
Study design
The study is designed as an observational investigation in which the effects
on sympathetic activity will be investigated in patients undergoing TAVI or
SAVR.
Study burden and risks
Participants will have no direct benefit from the study itself. The benefit of
this study consists of the knowledge the investigators can gain from this study
about the effects on cardiac sympathetic activity after TAVI compared to SAVR.
The possible risks that participants are exposed to are minor.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Severe symptomatic native aortic valve stenis
Percutaneous or surgical aortic valve replacement
Exclusion criteria
Previous aortic valve replacement
Surgical aortic valve replacement combined with CABG or other valve surgery
Severe infection
Recent myocardial infarction or stroke
Enrolled in another investigational study
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 | NL39028.018.11 |