Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve

Aortic Valve Stenosis Clinical Trial

— EASE-IT  

Official title:

Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127580
• Other study ID #: EASE-IT
• Status: Completed
• First received: April 29, 2014
• Last updated: April 26, 2018
• Start date: April 2014
• Est. completion date: May 2016

Study information

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

Clinical Trial Summary

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry.

We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Description:

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is usually 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 is aiming 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 and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke.

• The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an indication for TAVI as to the Edwards THV IFU

• Eligible for TABI with AND without BAV

• Signed informed consent

Exclusion Criteria:

• Logistic EuroSCORE I >50%

• Mitral or tricuspid valvular insufficiency (> grade II)

• Previous aortic valve replacement

• Uncontrolled atrial fibrillation

• Left ventricular or atrial thrombus by echocardiography

• Recent cerebrovascular event (within the last 3 months)

• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• BAV

• without BAV

Locations

Country	Name	City	State
Germany	Klinikum Augsburg	Augsburg
Germany	Herz- und Gefäß-Klinik GmbH Bad Neustadt	Bad Neustadt an der Saale
Germany	Schüchtermann-Schiller'sche Kliniken	Bad Rothenfelde
Germany	Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil	Bochum	Nordrhein-Westfalen
Germany	Uniklinik Essen	Essen
Germany	Clinic for Cardiac Surgery Karlsruhe	Karlsruhe	Baden-Württemberg
Germany	Uniklinik Köln	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Strauch J, Wendt D, Diegeler A, Heimeshoff M, Hofmann S, Holzhey D, Oertel F, Wahlers T, Kurucova J, Thoenes M, Deutsch C, Bramlage P, Schröfel H. Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the ao — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VARC2 criteria	comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).	3 months