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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Aortic Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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with BAV

patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve

with BAV

Intervention Type OTHER

balloon dilation of the aortic valve prior to implantation of the THV

without BAV

patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve

without BAV

Intervention Type OTHER

no balloon dilation of the aortic valve prior to implantation of the THV

Interventions

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with BAV

balloon dilation of the aortic valve prior to implantation of the THV

Intervention Type OTHER

without BAV

no balloon dilation of the aortic valve prior to implantation of the THV

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No