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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: with BAV; Other: without BAV

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 Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Karlsruhe, Baden-Württemberg, Germany, 76133
      • Medizinische Klinik IV, Städtisches Klinikum Karlsruhe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for transfemoral transcatheter valve implantation with commercially available Edwards Transcatheter Heart Valves.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with BAV; patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve	Other: with BAV; balloon dilation of the aortic valve prior to implantation of the THV
without BAV; patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve	Other: without BAV; no balloon dilation of the aortic valve prior to implantation of the THV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Gerhard Schymick, MD, Stadtisches Klinikum Karlsruhe; Principal Investigator: David Wendt, PD MD, Westdeutsches Herzzentrum Essen

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• registry on-line eCRF website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: THV (trans-catheter heart valve); severe aortic stenosis; pre-dilation; rapid pacing; BAV (balloon artery valvuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EASE-IT-TF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No