Brief Title
Transcatheter Aortic Valve Implantation Without Predilation
Official Title
Use of the Self-Expanding Medtronic CoreValve Prosthesis Without Predilation in Patients With Severely IMPaired Left-VentrIcular Ejection Fraction for TAVI Trial - The SIMPLIFy TAVI Trial
Brief Summary
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for
predilation of the native aortic valve is associated with a reduction of the composite
primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction
(LVEF ≤35%).
Detailed Description
Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical
aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with
symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive
operative risk. Before deployment of transcatheter heart valves (THV), current medical
practice requires right-ventricular rapid burst pacing (>180 bpm) with induction of a
functional cardiac arrest for up to 30 seconds for balloon aortic valvuloplasty (BAV). This
step is thought to be necessary to predilate the native aortic valve and to facilitate an
accurate positioning of the THV. However, BAV has been shown to have numerous detrimental
effects: i) the functional cardiac arrest induced by rapid pacing for BAV leads to transient
coronary, cerebral, and renal ischemia. ii) In patients with impaired left ventricular
ejection fraction, prolonged cardiac depression after rapid pacing is observed and may result
in hemodynamic failure and systemic inflammatory response syndrome (SIRS), which are both
associated with a high peri-procedural mortality. iii) BAV has been identified as a major
source of embolization of thrombotic and valvular material and increases the risk for
coronary obstruction with subsequent myocardial infarction and stroke. iv) the local trauma
in the left-ventricular outflow tract caused by BAV contributes to conduction disturbances
with the need for permanent pacemaker implantation after TAVI.
A non-randomized pilot study by Grube et al. (JACC Interventions 2011) has recently shown
that TAVI without BAV is feasible and safe, since self-expanding THV are able to "dilate" the
stenosed aortic valve through the radial forces of the self-expanding nitinol frame, in which
the prosthesis is mounted. According to the mentioned study, omitting BAV allows the delivery
of the THV in a controlled fashion without hemodynamic compromise of the patient.
Patients with LVEF≤35% will be randomized (like the flip of a coin) to TAVI without BAV
(experimental group) or TAVI with BAV for predilation (control group).
Study Type
Interventional
Primary Outcome
Primary composite efficacy endpoint
Secondary Outcome
Cardiovascular & all-cause mortality
Condition
Aortic Stenosis
Intervention
TAVI without BAV
Study Arms / Comparison Groups
TAVI without predilation
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
110
Start Date
January 2013
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- LVEF ≤35%
- Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
- Males or females at least 18 years of age
- Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20%
and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or
severe COPD)
- Signed informed consent
Exclusion Criteria:
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker,
resynchronization device, implanted defibrillator)
- Patients with a pre-existing class I or class II indication for new pacemaker
implantation according to the 2007 ESC guidelines
- Lack of written informed consent, severe mental disorder, drug/alcohol addiction
- Life expectancy < 1 year
- Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine,
clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately
premedicated
- Recent myocardial infarction (STEMI within the last 3 months)
- Left ventricular or atrial thrombus by echocardiography
- Uncontrolled atrial fibrillation
- Mitral or tricuspidal valvular insufficiency (> grade II)
- Previous aortic valve replacement with mechanical valve
- Evolutive or recent cerebrovascular event (within the last 3 months)
- Vascular conditions that make insertion and endovascular access to the aortic valve
impossible
- Symptomatic carotid or vertebral arterial narrowing (>70%) disease
- Abdominal or thoracic aortic aneurysm in the path of the delivery system
- Bleeding diathesis or coagulopathy or patient refusing blood transfusion
- Active gastritis or peptic ulcer disease
- Severely impaired renal function, GFR < 30 ml/min
- Participation in another drug or device study that would jeopardize the appropriate
analysis of end-points of this study.
- High probability of non-adherence to the follow-up requirements (due to social,
psychological or medical reasons)
- Pregnancy
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Georg Nickenig, MD, +49-228-287-15507, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01539746
Organization ID
SIMPLIFy TAVI Trial
Responsible Party
Principal Investigator
Study Sponsor
University Hospital, Bonn
Study Sponsor
Georg Nickenig, MD, Principal Investigator, Department of Medicine II, University Hospital Bonn
Verification Date
January 2013