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

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Brief Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

VARC2 criteria

Condition

Aortic Valve Stenosis

Intervention

BAV

Study Arms / Comparison Groups

 with BAV
Description:  Patients undergoing TA-TAVI WITH predilation of the AV (Group A)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

April 2014

Completion Date

May 2016

Primary Completion Date

March 2016

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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Holger Schröfel, MD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT02127580

Organization ID

EASE-IT

Responsible Party

Sponsor

Study Sponsor

Institut für Pharmakologie und Präventive Medizin

Study Sponsor

Holger Schröfel, MD, Principal Investigator, Clinic for Cardiac Surgery Karlsruhe

Verification Date

April 2018