Post-TAVI Coronary Access Study

NCT04649190 | Completed

• 1 other identifier: SHEBA-13-0685-IB-CTIL-B
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an even greater concern, because this lower-risk patient group has a greater cumulative risk of requiring coronary angiography for acute coronary events compared to their octogenarian counterparts. It is only speculated that the intra-annular position of the self-expandable valves together with the frame covering coronary ostia would impose a significant technical challenge as compared to the balloon-expandable valve (1). However, this remains to be proven. With any valve used, increased catheter manipulations may result in longer fluoroscopy times, larger volumes of contrast, and reduced imaging quality due to non-selective injections (2). Although complex, coronary procedures after TAVR are considered relatively safe and feasible on experience hands (3-6). A number of techniques to increase the likelihood of successful coronary intubation after TAVR have been described in the published reports and include the use of intracoronary guidewires (1), as well as balloon-assisted tracking with guideliner extension (7). It is therefore essential to fully understand the potential challenges of coronary angiography and PCI in this specific patient population. Guidance by a specific algorithm may help to overcome difficulties in coronary angiography and facilitate selective coronary intubation particularly during primary PCI (8).

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• PCI device success

  5 year

Secondary Outcomes (7)

• Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion

  5 year

• Successful withdrawal of the device delivery system

  5 year

• Attainment of a final in-stent or in-scaffold residual stenosis of <20%

  5 year

• Final TIMI flow

  5 year

• Successful selective engagement of guiding catheter

  5 year

Study Arms (1)

TAVI

Device: TAVI

Interventions

TAVI DEVICE

Coronary access for PCI after TAVI

TAVI

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who underwent TAVI at any time point prior to index PCI procedure, and who have clinical indication for PCI will be included in the present study. Consecutive subjects of both genders will be enrolled at various sites in Europe, United States and Asia (See Appendix 1). The study procedures, clinical management and follow up will be done at each participating center.

You may qualify if:

• Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
• Clinical indication for PCI

You may not qualify if:

• Prior TAVI valve-in-valve procedures
• Prior TAVI-in-TAVI procedures

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2010
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)