Improving coronary access after heart valve replacement
Coronary ANgiography and ACCESS Following Implantation of a Supra-Annular Transcatheter Heart Valve With Commissural Alignment: The CAN-ACCESS Pilot Study
NA · University of British Columbia · NCT05075590
This study is testing the best ways to access the coronary arteries after patients have a heart valve replacement using a specific type of valve to see how well different techniques work.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of British Columbia (other) |
| Locations | 4 sites (Harrisburg, Pennsylvania and 3 other locations) |
| Trial ID | NCT05075590 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the best techniques and equipment for selectively engaging coronary arteries after the implantation of the Evolut transcatheter heart valve (THV) during elective transfemoral TAVR procedures. Patients will undergo the procedure, and operators will attempt to engage both the right and left coronary arteries using standardized angiographic views. The study will involve the assessment of angiographic images and post-TAVR CT scans to determine the success of coronary engagement. The choice of catheters and tools will be left to the discretion of the operators, ensuring a tailored approach to each patient's needs.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective transfemoral TAVR with the Evolut THV.
Not a fit: Patients with hemodynamic or respiratory instability, advanced chronic kidney disease, or those who have had prior coronary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of coronary access during TAVR procedures, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on coronary engagement techniques, this specific approach focusing on the Evolut THV and commissural alignment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Harrisburg, Pennsylvania and 3 other locations
- UPMC Harrisburg — Harrisburg, Pennsylvania, United States (NOT_YET_RECRUITING)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Janarthanan Sathananthan, MBChB, MPH — University of British Columbia
- Study coordinator: Pavneet Grewal
- Email: pgrewal@cci-cic.org
- Phone: 604-875-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Angiography, Transcatheter Aortic Valve Replacement, elective transfemoral TAVR, Evolut valve, Supra-Annular Transcatheter Heart Valve, Commissural Alignment, Coronary Access