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

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Procedure: without BAV; Procedure: BAV

• Registration Number: NCT02127580
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
without BAV	without BAV	Patients undergoing TA-TAVI WITHOUT predilation of the AV
with BAV	BAV	Patients undergoing TA-TAVI WITH predilation of the AV (Group A)

Primary Outcome Measures

Name	Time	Method
VARC2 criteria	3 months	comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Trial Locations

Locations (7)

Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Clinic for Cardiac Surgery Karlsruhe; 🇩🇪 Karlsruhe, Baden-Württemberg, Germany

Uniklinik Köln; 🇩🇪 Köln, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Herz- und Gefäß-Klinik GmbH Bad Neustadt; 🇩🇪 Bad Neustadt an der Saale, Germany

Schüchtermann-Schiller'sche Kliniken; 🇩🇪 Bad Rothenfelde, Germany

Uniklinik Essen; 🇩🇪 Essen, Germany