To compare safety and efficacy of EVOLUT R/Pro vs. SAPIEN3 Ultra for the treatment of a failing surgical aortic bioprosthesis
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is device success by VARC-II at 30 days, defined by:
- Absence of procedural mortality AND
- Correct positioning of a single prosthetic heart valve into the proper
anatomical location AND
- Intended performance of the prosthetic heart valve (no prosthesis- patient
mismatch and mean aortic valve gradient < 20 mmHg or peak velocity
< 3 m/s, AND no moderate or severe prosthetic valve regurgitation)
- Clinically significant prosthesis patient mismatch is defined by EOAi < 0.85
cm2/m2 (< 0.70 if BMI > 30kg/m2).
Co-primary endpoint is efficacy at 1 year defined by the composite of all-cause
death, disabling stroke and rehospitalization for valve related problems.
Secondary outcome
Clinical endpoints as defined by the most recent VARC document will be
collected in an eCRF (including need for permanent pacemaker).
Cardiovascular rehospitalisation
Coronary obstruction requiring intervention/operation
New conduction disorders
Prosthetic valve function, as measured by trans thoracic echocardiography:
- Left ventricular ejection fraction (%)
- Peak velocity (m/s)
- Mean gradient (mmHg)
- Effective orifice area (cm2)
- Indexed effective orifice area (m2/cm2)
- Prosthetic aortic valve regurgitation
Background summary
Approximately 80% of surgical aortic valve replacements (SAVR) is performed
using a bioprosthesis. Durability of surgical bioprostheses varies based on the
patient*s age at the moment of implantation, type and size etc. Redo open-heart
surgery for a degenerated aortic bioprosthesis is a relatively high-risk
procedure with reported procedural mortality of 4 - 9% and overall high
morbidity including stroke, bleeding and conduction disorders.
Transcatheter aortic valve replacement (TAVI) has become the preferred
treatment for degenerated aortic bioprostheses in elderly patients. The median
time since index SAVR and TAVI for bioprosthetic valve degeneration is
typically 8 - 10 years. TAVI in this setting has proven to have equally
favorable results as in native aortic valves. Furthermore, a US based
retrospective analysis from the National Readmission Database claims reported
better short term survival and less morbidity with TAVI vs. redo SAVR. Balloon
expandable and self-expanding transcatheter heart valves (THV) can be used for
TAVI in a degenerated bioprosthesis and each have specific assets and
limitations. The Sapien3 Ultra and EVOLUT R/Pro are the 2 most commonly used
THV platforms in contemporary clinical practice including treatment of failing
surgical aortic bioprostheses.The balloon expandable SAPIEN3 is an
intra-annularly functioning THV which is fundamentally different from the
supra-annularly functionaning self-expanding Evolut platform. A supra-annular
design may offer superior hemodynamic THV performance but may be at higher risk
for paravalvular leaks and conduction disorders. Whether other potential
hazards related to TAVI in a failing surgical aortic bioprosthesis (e.g.
coronary obstruction, aortic rupture) is different for both THV designs is
unsettled.
Study objective
To compare safety and efficacy of EVOLUT R/Pro vs. SAPIEN3 Ultra for the
treatment of a failing surgical aortic bioprosthesis
Study design
International multi-center randomized study with 1:1 randomization to TAVI with
SAPIEN3 Ultra or Evolut R/Pro.
Intervention
Following screening and signing the informed consent form, patients will be
randomized in the cathlab or hybrid operating room prior to arterial access:
• SAPIEN3 Ultra
• EVOLUT R/Pro
Patients are admitted prior to the TAVI procedure per local practice. TAVI
procedure is executed per local standard (use of ancillary devices (e.g.
dedicated large-bore closure devices, cerebral embolic protection devices) and
techniques (e.g. valve fracture) are per operator*s discretion.
Antithrombotic regimen is at the operator*s discretion. In addition, the TAVI
procedure is preferably performed under local anaesthesia/conscious sedation.
Only transfemoral approach is allowed.
Post procedure care is per local standard.
Clinical assessment at the outpatient clinic will occur per local standard of
care 1 month and 1 year post TAVI. A follow up transthoracic echocardiography
after TAVI will be performed pre-discharge or at 30 days and at 1 year.
Study burden and risks
This study may prove superiority of one THV design over the other in terms of
valve performance, which may translate in improved long-term outcome.
In contrast, patients may be exposed to an inferior THV design in the context
of a failing surgical bioprosthesis. Eligibility to participate in the study
will be confirmed by the local multi-disciplinary heart valve team.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
o Age >= 65 years
o Failing surgical aortic bioprosthesis requiring valve replacement and
eligible for transfemoral TAVI per heart team consensus based on multi-modality
imaging assessment (including echocardiography and multidetector CT).
o Written informed consent
Exclusion criteria
o Not eligible for Transfemoral TAVI with SAPIEN3 and Evolut R/Pro
o Multi-valve defects requiring intervention
o Clinically unstable and/or inotropic/vasopressor /mechanical support.
o Known mural thrombus in the left ventricle
o Presence of a mechanical aortic valve
o History of recent (within 1 month) stroke or TIA
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 | NL76548.078.21 |