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

NCT02760771 | Completed

• 1 other identifier: EASE-IT-TF
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

THV (trans-catheter heart valve); severe aortic stenosis; pre-dilation; rapid pacing; BAV (balloon artery valvuloplasty

Outcome Measures

Primary Outcomes (1)

• Combination of all-cause mortality, stroke, non-fatal myocardial infarction, acute kidney injury, or pacemaker implantation

  within 30 days after TAVI

Secondary Outcomes (5)

• 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

Study Arms (2)

with BAV

patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) with predilation of the aortic valve

Other: with BAV

without BAV

patients undergoing transfemoral trans-catheter aortic valve implantations (TF-TAVI) without predilation of the aortic valve

Other: without BAV

Interventions

with BAV OTHER

balloon dilation of the aortic valve prior to implantation of the THV

with BAV

without BAV OTHER

no balloon dilation of the aortic valve prior to implantation of the THV

without BAV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Signed informed consent
• Males or females
• At least 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (1)

Medizinische Klinik IV, Städtisches Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Related Publications (2)

• 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.

  PMID: 31673387 DERIVED

• 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.

  PMID: 27846807 DERIVED

Related Links

• registry on-line eCRF website

MeSH Terms

Conditions

Aortic Valve Stenosis; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gerhard Schymick, MD

  Städtisches Klinikum Karlsruhe

  PRINCIPAL INVESTIGATOR

• David Wendt, PD MD

  Westdeutsches Herzzentrum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: May 1, 2016
• Primary Completion: June 8, 2017
• Study Completion: December 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

DE (1)