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Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT)

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ClinicalTrials.gov Identifier: NCT02127580
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

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).


Condition or disease Intervention/treatment
Aortic Valve Stenosis Procedure: BAV Procedure: without BAV

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry
Actual Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
with BAV
Patients undergoing TA-TAVI WITH predilation of the AV (Group A)
Procedure: BAV
without BAV
Patients undergoing TA-TAVI WITHOUT predilation of the AV
Procedure: without BAV



Primary Outcome Measures :
  1. VARC2 criteria [ Time Frame: 3 months ]
    comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127580


Locations
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Germany
Clinic for Cardiac Surgery Karlsruhe
Karlsruhe, Baden-Württemberg, Germany, 76185
Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil
Bochum, Nordrhein-Westfalen, Germany, 44789
Klinikum Augsburg
Augsburg, Germany, 86156
Herz- und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, Germany, 97615
Schüchtermann-Schiller'sche Kliniken
Bad Rothenfelde, Germany, 49214
Uniklinik Essen
Essen, Germany, 45147
Uniklinik Köln
Köln, Germany, D-50937
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
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Principal Investigator: Holger Schröfel, MD Clinic for Cardiac Surgery Karlsruhe
Principal Investigator: Justus Strauch, Prof. Klinik für Herz- und Thoraxchirurgie

Additional Information:

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02127580     History of Changes
Other Study ID Numbers: EASE-IT
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Keywords provided by Institut für Pharmakologie und Präventive Medizin:
THV
BAV
pre-dilation
Aortic valve stenosis

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction