The study purpose is to evaluate the acute and long term clinical performance and safety of the Evolut* PRO System used in routine hospital setting for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The all-cause mortality rate at 30 days post procedure meets a performance goal
of 5.5%.
Secondary outcome
•The percentage of subjects graded as none or trace total aortic regurgitation
at discharge is greater than a prespecified performance goal of 67.1%.
•VARC-2 safety and efficacy endpoints as well as hemodynamic performance
metrics (incl. mean gradient, effective orifice area and prosthetic
regurgitation).
Background summary
The Evolut* PRO System builds upon the improvements of the Evolut R platform
with the added feature of an external pericardial wrap covering the first 1.5
cells of the inflow region. This feature is intended to reduce prosthetic
aortic regurgitation. The Evolut* PRO System has completed comprehensive bench
testing, and in May of 2016, Medtronic began enrollment in a multi-center
clinical study in the United States (US) to confirm the safety and performance
of the Evolut* PRO System in high or extreme risk patients with severe
symptomatic aortic stenosis. Taken together, these data demonstrate the Evolut*
PRO System is safe, performs as intended, and that the benefits outweigh the
risks for use in the intended patient population, resulting in CE marking on 28
July 2017.
More background information can be found on page 14-15 of the CIP
Study objective
The study purpose is to evaluate the acute and long term clinical performance
and safety of the Evolut* PRO System used in routine hospital setting for the
treatment of symptomatic native aortic valve stenosis or a stenosed,
insufficient, or combined surgical bioprosthetic valve failure necessitating
valve replacement.
Study design
Prospective, single-arm, multi-center, interventional post-market study.
After signing informed consent, eligible subjects will be implanted with the
Evolut* PRO.
Intervention
Main collected data will be:
•Baseline subject demographics, medical history, anatomically eligibility for
the CoreValve* Evolut* PRO system, STS-Risk score and Katz ADL
•Procedural/discharge evaluations
•TTE at baseline, discharge, 1-year, 3-year, and 5-year follow-up visit
•12-lead ECG at baseline and discharge
•NYHA at baseline, 30-day, 1-year, 3-years, and 5-year follow-up visit
•Quality of Life assessment at baseline, 30-day, 1-year, 3-year, and 5-year
follow-up visit
Study burden and risks
Participation in this study will not exposure the patients to a greater risks
than if he/she receiving the CoreValve* Evolut* PRO system, outside of the
study.
There might be other discomforts and risks related to CoreValve* Evolut* PRO
system or study that are not foreseen at this time.
The risks associated with the CoreValve* Evolut* PRO system are minimized by
selecting qualified physicians/ investigators to implant the CoreValve* Evolut*
PRO system, selecting an appropriate patient population via inclusion/exclusion
criteria and monitoring patient progress and events reported for this study.The
review and minimization of the potential risks to the patient and the potential
benefits to the patient support the conduct of this study.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
Patients must meet ALL of the following inclusion criteria:
1.Symptomatic native aortic valve stenosis or a stenosed,
insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
2.High or greater risk for surgical aortic valve replacement as estimated by the heart team OR, 75 years or older and at intermediate risk for surgical AVR (STS risk score >=4% or with an estimated hospital mortality >=4% as assessed by the heart team)
3.Acceptable candidate for treatment with the Evolut* PRO system in conformity with the local regulations
4.Able and willing to return to the implanting site at the following follow-up visits: 1-year, 3-year and 5-year
5.Written informed consent obtained without assistance from a legal representative prior to enrollment in the study
Exclusion criteria
Patients are NOT eligible for study participation if they meet ANY of the following exclusion criteria:;1.Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
2.Preexisting mechanical heart valve in aortic position
3.Ongoing sepsis, including active endocarditis
4.Anatomically not suitable for the Evolut* PRO system
5.Estimated life expectancy of less than 1 year
6.Participating in another trial that may influence the outcome of this study
7.Need for emergency surgery for any reason
8.Inability to understand and respond to the quality of life questionnaire
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 | NCT03417011 |
| CCMO | NL64028.100.17 |