The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on periprosthetic aortic regurgitation and additional focus on other clinical and…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is post-TAVI periprosthetic aortic regurgitation measured
with 3DTEE and new developed special software.
Secondary outcome
Secondary objectives of this study include: investigating the value of
different imaging modalities in evaluating periprosthetic regurgitation after
TAVI and studying the difference in clinical endpoints according to VARC-2
definitions and quality of life after TAVI between two available aortic valve
prostheses.
Background summary
Transcatheter aortic valve implantation (TAVI) is a good alternative treatment
for patients with severe aortic valve stenosis with similar mid-term success
rates as compared to surgery. Periprosthetic aortic regurgitation after TAVI
remains an important limitation of this technique. Moderate to severe
periprosthetic aortic regurgitation occurs in 15-45% of the cases and it is an
independent predictor of mortality after TAVI. Little is known about potential
differences in severity of periprosthetic aortic regurgitation among different
types of aortic valve prosthesis.
Study objective
The current randomized study aims to evaluate potential differences between the
Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main
focus on periprosthetic aortic regurgitation and additional focus on other
clinical and imaging endpoints. Primary objective of this study is to
investigate the difference in the severity of periprosthetic aortic
regurgitation, measured with 3-dimensional transesophageal echocardiography
(3DTEE), between patients undergoing the implantation of the Edwards SAPIEN
bioprosthesis versus patients receiving the Medtronic CoreValve®
bioprosthesis.
Study design
single-center, randomised controlled trial. 108 patients will be randomly
allocated in a one-to-one ratio to undergo transcatheter implantation of either
an Edwards SAPIEN (n=54) or a Medtronic CoreValve® bioprosthesis (n=54).
Randomization will be performed using sealed envelopes.
Intervention
All TAVI will be performed via the femoral artery. One group of patients will
receive the balloon expandable Edwards SAPIEN bioprosthesis and the other group
will receive the self-expanding Medtronic CoreValve®.
Study burden and risks
Patients participating in this study are planned to undergo a TAVI procedure in
our centre. Which one of the two available types of bioprosthesis they will
receive, is normally randomly chosen by the operator. Both aortic valve
bioprostheses, Edwards SAPIEN and Medtronic CoreValve® are safe and are
approved in Europe. Both valve bioprostheses are used on a regular basis in our
center and our interventional cardiologists are experienced with implanting
both of them (Utrecht data show 0% in hospital mortality with both CoreValve
and Edwards in 2012 and 2013). Thus, based on the available knowledge
randomization for the type of bioprosthesis does not bring additional
procedural risk for the patients. As part of this study, patients will undergo
a series of additional investigations, including 3DTEE, MRI and 24-hour urine
collection. 3DTEE represents a valuable and generally safe diagnostic tool for
the evaluation of cardiac performance and the function of the valve prosthesis
and is routinely performed in this institution. It is essential in the
quantified assessment of periprosthetic regurgitation. Possible risks
associated with 3DTEE include infection and oral or esophageal mucosal injury.
During the MRI made at follow up, no contrast agent will be given to the
patient. Therefore, when safety guidelines are followed properly, MRI poses no
known health risks to the patient and produces no physical side effects. There
are no risks related to the 24-hour urine collection and the quality of life
questionnaire. Using the additional MRI, the urine examination and the quality
of live questionnaire, extra information will be gained in regard to the
consequences of TAVI procedure for other organs of the body and the quality of
life of patients undergoing this procedure. Using this extra information, we
might be able to introduce measures for improving the safety of TAVI and the
outcome of patients undergoing this procedure.
heidelberglaan 100
Utrecht 3584CX
NL
heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1)Patient is 18 years of age or older and diagnosed with severe symptomatic aortic stenosis, judged inoperable or at high surgical risk (EuroSCORE < 15%) and deemed eligible for TAVI by a consensus among a cardiologist and a cardiac surgeon (heart-team), 2) Or a patient who is considered to be operable by the heart-team, but who chooses to undergo TAVI instead of conventional surgery, 3) Annulus diameter *18 and *28, 4) Patients who undergo a transcatheter aortic valve implantation via the transfemoral approach
Exclusion criteria
1) Patients with contraindications for transesophageal echocardiography (TEE)
2) Patients unable to give informed consent
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 |
|---|---|
| ClinicalTrials.gov | NCT01982032 |
| CCMO | NL43116.041.13 |