Clinical trial NCT02127580: Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve
Official title: Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: THV
BAV
pre-dilation
Aortic valve stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2014-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: VARC2 criteria
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Clinic for Cardiac Surgery Karlsruhe
state: Baden-Württemberg
city: Bochum
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil
state: Nordrhein-Westfalen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Neustadt an der Saale
country: Germany
facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller'sche Kliniken
city: Essen
country: Germany
facility: Uniklinik Essen
city: Köln
country: Germany
facility: Uniklinik Köln
Study officials:
affiliation: Clinic for Cardiac Surgery Karlsruhe
name: Holger Schröfel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Herz- und Thoraxchirurgie
name: Justus Strauch, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strauch J, Wendt D, Diegeler A, Heimeshoff M, Hofmann S, Holzhey D, Oertel F, Wahlers T, Kurucova J, Thoenes M, Deutsch C, Bramlage P, Schrofel H. Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):771-777. doi: 10.1093/ejcts/ezx397.
citation: Bramlage P, Strauch J, Schrofel H. Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT). BMC Cardiovasc Disord. 2014 Nov 18;14:160. doi: 10.1186/1471-2261-14-160.