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

Completed

• Conditions: Aortic Stenosis
• Interventions: Other: without BAV; Other: with BAV

• Registration Number: NCT02760771
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Primary Completion: 2017-06-08
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
without BAV	without BAV	patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve
with BAV	with BAV	patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve

Primary Outcome Measures

Name	Time	Method
Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation	within 30 days after TAVI

Secondary Outcome Measures

Name	Time	Method
Non-fatal myocardial infarction	within 30 days after TAVI
pacemaker implantation	within 30 days after TAVI
acute kidney injury	within 30 days after TAVI
All-cause mortality	within 30 days after TAVI
Stroke	within 30 days after TAVI

Trial Locations

Locations (1)

Medizinische Klinik IV, Städtisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Baden-Württemberg, Germany