The study objective is to evaluate the clinical outcome of percutaneous aortic valve implantation in consecutive *real world* patients with severe aortic valve stenosis intended to be treated with the Medtronic CoreValve System.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for this trial is Major Adverse Cardiac & Cerebrovascular
Events (MACCE) at 30 days post procedure.
With MACCE defined as a composite of:
- All cause mortality
- Myocardial Infarction (Q-wave and non-Q-wave)
- Emergent cardiac surgery or percutaneous re-intervention
- Stroke
Secondary outcome
- Device success, defined as a composite of:
- Successful device delivery;
- Stable device placement;
- Intact retrieval of the delivery catheter;
- Successful device function as assessed immediately post-procedure by
angiography including non-compromised flow in coronary arteries (without
obstruction) device position (no migration) and a mean gradient as determined
invasively of <15mmHg and <= 2 aortic regurgitation
- Procedural success, defined as device success with absence of in-hospital
MACCE
- All cause mortality at discharge, 1 month and all subsequent follow-up visits
- Incidence of Myocardial Infarction (Q-wave and non-Q-wave) at discharge, 1
month, and all subsequent follow-up visits
- Incidence of emergent cardiac surgery or percutaneous re-intervention at
discharge, 1 month, and all subsequent follow-up visits
- Incidence of stroke at discharge, 1 month, and all subsequent follow-up visits
- Incidence of composite endpoint of stroke and all cause mortality at
discharge, 1 month, and all subsequent follow-up visits
- Evidence of structural valve deterioration at discharge, 1 month and all
subsequent follow-up visits
- Evidence of non-structural valve dysfunction at discharge, 1 month and all
subsequent follow-up visits
- Incidence of MACCE at discharge, 6 months and all subsequent follow-up visits
- Incidence of Acute Kidney Injury at baseline and discharge
- Incidence of bleeding events at discharge, 1 month, and all subsequent
follow-up visits
- Incidence of pacemaker implantation as a result of new onset conduction
disturbances at discharge, 1 month and all subsequent follow-up visits
- Functional improvement assessed by NYHA classification at 1 month and all
subsequent follow-up visits compared to baseline
- All Serious Adverse Events and Serious Adverse Device Effects at discharge, 1
month and all subsequent follow-up visits
- Patient health status evaluated by Quality of Life Questionnaires (EQ-5D) at
baseline, 1 month and all subsequent follow-up visits
- Patient health status evaluated by Health Survey (SF-12) at baseline, 1 month
and all subsequent follow-up visits
- Incidence of stent placement due to access site vessel complications
- Incidence of vascular surgery due to access site vessel complications
Background summary
The 18F CoreValve ReValving* System (renamed to *Medtronic CoreValve System*
after acquisition from CoreValve Inc. by Medtronic Inc. on 09 April 2009) was
approved for CE marking effective March 1, 2007. CE Mark Approval is EU
Certificate 252.673.
Study objective
The study objective is to evaluate the clinical outcome of percutaneous aortic
valve implantation in consecutive *real world* patients with severe aortic
valve stenosis intended to be treated with the Medtronic CoreValve System.
Study design
A Multi-center, Interventional, Prospective, Post-Market Release Study
Intervention
Patients enrolled in this interventional PMR study should be treated according
to normal hospital routine practice and in line with the applicable guidelines
on percutaneous heart valve implantation.
Study burden and risks
The risks associated with implantation of Medtronic CoreValve System are
similar to the risks associated with any percutaneous procedure and with any
surgical valve replacement, as well as those that are more specific to the
Percutaneous Aortic Valve components and use.
There is no direct benefit associated to participation in this study. The main
benefit of the procedure is the restoration of aortic heart valve function.
The information obtained during this study may be used scientifically to help
others who suffer from the same medical problem. The information from this
study can help doctors to understand how to improve the handling and treatment
of complications related to the Medtronic CoreValve aortic valve implantation,
both in your case and in future patients. Information collected in this study
can support the development of new devices and therapies.
Endepolsdomein 5
6229 GW Maastricht
NL
Endepolsdomein 5
6229 GW Maastricht
NL
Listed location countries
Age
Inclusion criteria
1. Patient with severe aortic valve stenosis requiring treatment.
2. Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economic context.
3. Patient is above the minimum age as required by local regulations to be participating in a clinical study.
4. The patient has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (*Patient Informed Consent Form*)
Exclusion criteria
1. Currently participating in another trial
2. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
3. Pregnancy
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 | NCT01074658 |
| CCMO | NL31841.060.10 |