Clinical trial NCT02760771: Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Official title: Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: THV (trans-catheter heart valve)
severe aortic stenosis
pre-dilation
rapid pacing
BAV (balloon artery valvuloplasty
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2016-05-04
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for transfemoral transcatheter valve implantation with commercially available Edwards Transcatheter Heart Valves.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation
timeFrame: within 30 days after TAVI
Secondary outcomes:
measure: All-cause mortality
timeFrame: within 30 days after TAVI
measure: Stroke
timeFrame: within 30 days after TAVI
measure: Non-fatal myocardial infarction
timeFrame: within 30 days after TAVI
measure: pacemaker implantation
timeFrame: within 30 days after TAVI
measure: acute kidney injury
timeFrame: within 30 days after TAVI
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Medizinische Klinik IV, Städtisches Klinikum Karlsruhe
state: Baden-Württemberg
Study officials:
affiliation: Städtisches Klinikum Karlsruhe
name: Gerhard Schymick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westdeutsches Herzzentrum Essen
name: David Wendt, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schymik G, Rudolph T, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Sykorova L, Okamoto M, Thoenes M, Deutsch C, Bramlage P, Butter C. Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry. Open Heart. 2019 Oct 3;6(2):e001082. doi: 10.1136/openhrt-2019-001082. eCollection 2019.
citation: Butter C, Bramlage P, Rudolph T, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Seilerova L, Schymik G. Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve - rationale and design of a multicentre registry (EASE-IT TF). BMC Cardiovasc Disord. 2016 Nov 15;16(1):223. doi: 10.1186/s12872-016-0390-4.