NCT05075590

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2.7 years

First QC Date

September 14, 2021

Last Update Submit

December 13, 2023

Conditions

Coronary AngiographyTranscatheter Aortic Valve Replacement

Keywords

elective transfemoral TAVREvolut valveSupra-Annular Transcatheter Heart ValveCommissural AlignmentCoronary AngiographyTranscatheter Aortic Valve ReplacementCoronary Access

Outcome Measures

Primary Outcomes (1)

  • 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: 1. 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. 2. Successful if selective engagement is achieved with placement of the coronary catheter in the coronary ostia and adequate opacification of the coronary vessels. 3. Unsuccessful if engagement is not possible and there is insufficient opacification of the coronary vessels.

    Immediately post-TAVR

Secondary Outcomes (5)

  • 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

    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.

    During TAVR procedure

Interventions

Coronary AngiographyDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
  • Written informed consent to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UPMC Harrisburg

Harrisburg, Pennsylvania, 17101, United States

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

NOT YET RECRUITING

Related Publications (11)

  • 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.

    PMID: 29701845RESULT

  • 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.

    PMID: 30883058RESULT

  • 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.

    PMID: 31679616RESULT

  • 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.

    PMID: 28315732RESULT

  • 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.

    PMID: 28988450RESULT

  • 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.

    PMID: 29566822RESULT

  • 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.

    PMID: 28078734RESULT

  • 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.

    PMID: 25720330RESULT

  • 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.

    PMID: 33069648RESULT

  • 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.

    PMID: 32192691RESULT

  • 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.

    PMID: 32192985RESULT

MeSH Terms

Interventions

Coronary Angiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Officials

  • Janarthanan Sathananthan, MBChB, MPH

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavneet Grewal

CONTACT

604-875-4111pgrewal@cci-cic.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional and Structural Cardiologist

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 13, 2021

Study Start

October 27, 2021

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

CA(3)US(1)