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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| The Centre for Cardiovascular Innovation - Centre d'Innovation Cardiovasculaire (CCI-CIC) | UNKNOWN |
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To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Angiography | Diagnostic Test | 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. |
| 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:
| Immediately post-TAVR |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavneet Grewal | Contact | 604-875-4111 | 22959 | pgrewal@cci-cic.org |
| Name | Affiliation | Role |
|---|---|---|
| Janarthanan Sathananthan, MBChB, MPH | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Harrisburg | Not yet recruiting | Harrisburg | Pennsylvania | 17101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29701845 | Result | 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. | |
| 30883058 | Result | 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 JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16. |
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| ID | Term |
|---|---|
| D017023 | Coronary Angiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
|
| Sunnybrook Health Sciences Centre | Not yet recruiting | Toronto | Ontario | M4N 3M5 | Canada |
|
| 31679616 | Result | 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 Nov;35(11):1437-1448. doi: 10.1016/j.cjca.2019.08.011. |
| 28315732 | Result | 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 Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available. |
| 28988450 | Result | 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):1339-1344. doi: 10.1002/ccd.27346. Epub 2017 Oct 8. |
| 29566822 | Result | 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. |
| 28078734 | Result | 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. doi: 10.1111/joic.12363. Epub 2017 Jan 11. |
| 25720330 | Result | 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. Epub 2015 Feb 27. |
| 33069648 | Result | 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. Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2542-2555. doi: 10.1016/j.jcin.2020.07.006. Epub 2020 Oct 14. |
| 32192691 | Result | 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. |
| 32192985 | Result | 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, George I, Kodali SK, De Backer O, Leon MB, Bapat VN. Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap. JACC Cardiovasc Interv. 2020 May 11;13(9):1030-1042. doi: 10.1016/j.jcin.2020.02.005. Epub 2020 Mar 16. |
| D000792 | Angiography |
| D011859 | Radiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006334 | Heart Function Tests |