Coronary Access After Supra-Annular THV Implantation

Transcatheter Aortic Valve Replacement Clinical Trial

— CAN-ACCESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05075590
• Other study ID #: H21-01704
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2023
• Source: University of British Columbia
• Contact: Pavneet Grewal
• Phone: 604-875-4111
• Email: pgrewal[@]cci-cic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).

2. Written informed consent to participate in the study.

Exclusion Criteria:

1. Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.

2. Advanced chronic kidney disease, defined as a GFR <30 ml/min.

3. Valve-in-valve TAVR

4. Prior CABG

5. Aorto-ostial coronary artery disease.

6. Prior PCI of the left main or right coronary ostium

Related Conditions & MeSH terms

• Coronary Angiography
• Transcatheter Aortic Valve Replacement

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	UPMC Harrisburg	Harrisburg	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Medtronic, The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (11)

Abdelghani M, Landt M, Traboulsi H, Becker B, Richardt G. Coronary Access After TAVR With a Self-Expanding Bioprosthesis: Insights From Computed Tomography. JACC Cardiovasc Interv. 2020 Mar 23;13(6):709-722. doi: 10.1016/j.jcin.2020.01.229. — View Citation

Asgar AW, Ouzounian M, Adams C, Afilalo J, Fremes S, Lauck S, Leipsic J, Piazza N, Rodes-Cabau J, Welsh R, Wijeysundera HC, Webb JG. 2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation. Can J Cardiol. 2019 N — View Citation

Barbanti M, Costa G, Picci A, Criscione E, Reddavid C, Valvo R, Todaro D, Deste W, Condorelli A, Scalia M, Licciardello A, Politi G, De Luca G, Strazzieri O, Motta S, Garretto V, Veroux P, Giaquinta A, Giuffrida A, Sgroi C, Leon MB, Webb JG, Tamburino C. — View Citation

Blumenstein J, Kim WK, Liebetrau C, Gaede L, Kempfert J, Walther T, Hamm C, Mollmann H. Challenges of coronary angiography and intervention in patients previously treated by TAVI. Clin Res Cardiol. 2015 Aug;104(8):632-9. doi: 10.1007/s00392-015-0824-5. Ep — View Citation

Boukantar M, Gallet R, Mouillet G, Belarbi A, Rubimbura V, Ternacle J, Dubois-Rande JL, Teiger E. Coronary Procedures After TAVI With the Self-Expanding Aortic Bioprosthesis Medtronic CoreValve, Not an Easy Matter. J Interv Cardiol. 2017 Feb;30(1):56-62. — View Citation

Htun WW, Grines C, Schreiber T. Feasibility of coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement using a Medtronic self-expandable bioprosthetic valve. Catheter Cardiovasc Interv. 2018 Jun;91(7):1339- — View Citation

Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb J — View Citation

Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular — View Citation

Pilgrim T, Windecker S. Expansion of transcatheter aortic valve implantation: new indications and socio-economic considerations. Eur Heart J. 2018 Jul 21;39(28):2643-2645. doi: 10.1093/eurheartj/ehy228. No abstract available. — View Citation

Tang GHL, Zaid S, Fuchs A, Yamabe T, Yazdchi F, Gupta E, Ahmad H, Kofoed KF, Goldberg JB, Undemir C, Kaple RK, Shah PB, Kaneko T, Lansman SL, Khera S, Kovacic JC, Dangas GD, Lerakis S, Sharma SK, Kini A, Adams DH, Khalique OK, Hahn RT, Sondergaard L, Geor — View Citation

Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary Angiography and Percutaneous Coronary Intervention After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2018 Mar 27;71(12):1360-1378. doi: 10.1016/j.jacc.2018.01.057. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total fluoroscopic time (mins) from catheter insertion to selective coronary engagement.		During TAVR procedure
Secondary	Total contrast use (ml) from catheter insertion to selective coronary engagement.		During TAVR procedure
Secondary	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
Secondary	Total number and types of wires and catheters used.		During TAVR procedure
Secondary	Description of type of technique utilized to achieve selective coronary engagement.	Report of description will be collected	During TAVR procedure