Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI
-
- STATUS
- Recruiting
-
- End date
- Aug 1, 2027
-
- participants needed
- 80
-
- sponsor
- Radboud University
Summary
Rationale:
Objective: To assess procedural hemodynamic measurements in patients with paravalvular
Study design: This is a prospective, single center clinical trial. Patients will receive a
TAVI. After implantation different hemodynamic indices of paravalvular leakage will be
assessed. At 1 month a
Study population: Approximately 80 patients with severe symptomatic
Intervention: Patients will undergo
Main study parameters/endpoints: The primary endpoint is defined as paravalvular leakage
Description
- INTRODUCTION AND RATIONALE
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients with severe symptomaticaortic valve stenosis and increased surgical risks due to advanced age and multiple comorbidity(2-4). However, in contrast to surgicalaortic valve replacement (SAVR), paravalvular leakage after TAVI is fairly common. More than moderate paravalvular leakage is associated with intermediate and long-term morbidity and mortality(5).
Since the introduction of TAVI, implantation- and device technology have improved
significantly. Nevertheless, mild paravalvular leakage remains a common finding after
implantation of new generation devices. Conflicting evidence exists regarding the impact
of mild versus none to trivial paravalvular leakage on mortality and morbidity. Several
factors might be of influence on these conflicting results. Patients with left
Furthermore, studies have used different definitions of paravalvular leakage, assessed
paravalvular leakage at different time intervals and used different prostheses. Since
paravalvular leakage might decrease over time in self- expandable TAVI devices, this
potentially influenced outcomes(11). The widely used VARC-2 criteria for paravalvular
leakage grading comprise echocardiographic measurements only(1). Especially quantitative
assessment of paravalvular leakage in the intermediate strata (mild-moderate) using
Hemodynamic parameters have been shown to be of great value in grading paravalvular
leakage post implantation(15-18). These objective parameters are easily obtained during
TAVI and have been shown to have prognostic relevance. All of these parameters are a
function of
Both echocardiographic and hemodynamic measures provide an estimation of the amount of
paravalvular leak. In contrast to
2. OBJECTIVES 2.1 Primary Objective To assess per-procedural hemodynamic indices of
paravalvular leakage and to relate these to paravalvular leakage as quantified by
2.2 Secondary Objectives To exploratory assess short- and long-term outcomes in patients with different severity of paravalvular leakage
3. STUDY DESIGN The study is designed as a single center, investigator-initiated, clinical trial.
In case patients want to participate there is no change of standard clinical care. After
TAVI, study participants will receive additional
4. STUDY POPULATION 4.1 Population (base) Patients with severe symptomatic aortic valve
Details
Condition |
|
---|---|
Age | 18years - 100years |
Treatment |
|
Clinical Study Identifier | NCT04281771 |
Sponsor | Radboud University |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Enable the functional cookies in order to view/reply the sharedadd your annotations.
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Publish Annotation
Are you sure you want to publish the annotation?
Delete AnnotationNote
Are you sure you want to delete the annotationnote?
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.