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
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|
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]|
|Actual Enrollment :||200 participants|
|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|
Patients undergoing TA-TAVI WITH predilation of the AV (Group A)
Patients undergoing TA-TAVI WITHOUT predilation of the AV
Procedure: without BAV
- 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).
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
|Clinic for Cardiac Surgery Karlsruhe|
|Karlsruhe, Baden-Württemberg, Germany, 76185|
|Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil|
|Bochum, Nordrhein-Westfalen, Germany, 44789|
|Augsburg, Germany, 86156|
|Herz- und Gefäß-Klinik GmbH Bad Neustadt|
|Bad Neustadt an der Saale, Germany, 97615|
|Bad Rothenfelde, Germany, 49214|
|Essen, Germany, 45147|
|Köln, Germany, D-50937|
|Principal Investigator:||Holger Schröfel, MD||Clinic for Cardiac Surgery Karlsruhe|
|Principal Investigator:||Justus Strauch, Prof.||Klinik für Herz- und Thoraxchirurgie|