Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)

Study Overview
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Brief Summary
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Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects. There is limited experience for the balloon expandable Edwards THV on the need for predilation (BAV). Experience so far has only been documented from smaller, uncontrolled case series. The investigators aim to document the incidence of several kinds of complications in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Detailed Description
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Aortic valve predilation aims at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as: Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia. In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality. BAV has been identified as a major source of thrombotic and valvular material, thus increasing the risk for coronary obstruction with subsequent myocardial infarction and/or stroke. The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture. The investigators aim to document the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a large, multicenter registry / prospective controlled cohort study to identify associations between patient related variables and outcomes.

Official Title
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Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Other: with BAV
* Other: without BAV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Males or females At least 18 years of age Exclusion Criteria: Logistic EuroSCORE I >40% Mitral or tricuspid valvular insufficiency (> grade II) Previous aortic valve replacement Uncontrolled atrial fibrillation Left ventricular or atrial thrombus by echocardiography High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) Patients with mobile structures on the leaflets Need for a cerebral protection device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with BAV<br>patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve | Other: with BAV<br>* balloon dilation of the aortic valve prior to implantation of the THV<br>|
| without BAV<br>patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve | Other: without BAV<br>* no balloon dilation of the aortic valve prior to implantation of the THV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation |  | within 30 days after TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | within 30 days after TAVI | 
| Stroke |  | within 30 days after TAVI | 
| Non-fatal myocardial infarction |  | within 30 days after TAVI | 
| pacemaker implantation |  | within 30 days after TAVI | 
| acute kidney injury |  | within 30 days after TAVI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THV (trans-catheter heart valve), severe aortic stenosis, pre-dilation, rapid pacing, BAV (balloon artery valvuloplasty