Recruiting

Coronary Access

Sponsor:

University of British Columbia

Code:

NCT05075590

Conditions

Coronary Angiography

Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary Angiography

Study Details

Brief summary:

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

Conditions

Coronary Angiography

Transcatheter Aortic Valve Replacement

Study ID

NCT05075590

Start date

Oct 27, 2021

Status verified date

Dec, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • The ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia [ Time Frame: Immediately post-TAVR ]

Central Contacts and Locations

Central contacts

Pavneet Grewal

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

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jackie Chow

604.875.5324jackie.chow@vch.ca

Principal Investigator:

Janarthanan Sathananthan, MBChB, MPH

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Elizabeth Grieve

604.682.2344egrieve@providencehealth.bc.ca

Principal Investigator:

Janarthanan Sathananthan, MBChB, MPH

More Information

Sponsor

University of British Columbia

Last update posted

Dec 20, 2023

Last verified

Dec, 2023

Keywords

  • elective transfemoral TAVR
  • Evolut valve
  • Supra-Annular Transcatheter Heart Valve
  • Commissural Alignment
  • Coronary Angiography
  • Transcatheter Aortic Valve Replacement
  • Coronary Access

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-12-20.