Coronary Access After Supra-Annular THV Implantation

Study Overview
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Brief Summary
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To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.

Detailed Description
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Patients will undergo elective transfemoral TAVR with the Evolut THV. The operators will attempt to selectively engage both the right and left coronary arteries through standardized angiographic views. The CCI-CIC CoreLabs will adjudicate angiographic views, post-TAVR CT scan, and determine if the coronaries were selectively engaged. Catheter choice, adjunctive tools if needed (e.g guide extension, wires etc) and engagement technique will be at the discretion of the operator. All images and fluoroscopic views will be anonymized, saved and imported to the CCI-CIC Angiographic and CT CoreLabs. Statistical analysis: Patient baseline and outcome data will be presented as mean and standard deviation (SD) for normally distributed variables, median and interquartile range (IQR) for non-normally distributed variables, and frequency and proportion for categorical variables.

Official Title
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Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study

Conditions
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Coronary Angiography, Transcatheter Aortic Valve Replacement

Intervention / Treatment
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* Diagnostic Test: Coronary Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA). Written informed consent to participate in the study. Exclusion Criteria: Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR. Advanced chronic kidney disease, defined as a GFR <30 ml/min. Valve-in-valve TAVR Prior CABG Aorto-ostial coronary artery disease. Prior PCI of the left main or right coronary ostium

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Coronary Angiography|Following TAVR, the operators will attempt to selectively engage both the right and left coronary arteries. Catheter choice and engagement technique will be at the discretion of the operator.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia | Coronary engagement will be classified as: Partially successful if non-selective engagement is achieved (catheter is unable to be placed in the coronary ostia) and there is adequate opacification of the coronary vessels. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels. | Immediately post-TAVR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement. |  | During TAVR procedure | 
| Total contrast use (ml) from catheter insertion to selective coronary engagement. |  | During TAVR procedure | 
| Type of wire and catheter used for successful right and left coronary engagement | Reporting of the wire and catheter type will be collected | During TAVR procedure | 
| Total number and types of wires and catheters used. |  | During TAVR procedure | 
| Description of type of technique utilized to achieve selective coronary engagement. | Report of description will be collected | During TAVR procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective transfemoral TAVR, Evolut valve, Supra-Annular Transcatheter Heart Valve, Commissural Alignment, Coronary Angiography, Transcatheter Aortic Valve Replacement, Coronary Access