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

Aortic Stenosis Clinical Trial

— EASE-IT-TF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760771
• Other study ID #: EASE-IT-TF
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: February 27, 2018
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Other:
• with BAV
balloon dilation of the aortic valve prior to implantation of the THV
• without BAV
no balloon dilation of the aortic valve prior to implantation of the THV

Locations

Country	Name	City	State
Germany	Medizinische Klinik IV, Städtisches Klinikum Karlsruhe	Karlsruhe	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation		within 30 days after TAVI
Secondary	All-cause mortality		within 30 days after TAVI
Secondary	Stroke		within 30 days after TAVI
Secondary	Non-fatal myocardial infarction		within 30 days after TAVI
Secondary	pacemaker implantation		within 30 days after TAVI
Secondary	acute kidney injury		within 30 days after TAVI

External Links

•   registry on-line eCRF website