Post-TAVI Coronary Access Study

Completed

• Conditions: Transcatheter Aortic Valve Replacement
• Interventions: Device: TAVI

• Registration Number: NCT04649190
• Lead Sponsor: Sheba Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Primary Completion: 2023-01-01
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
2. Clinical indication for PCI

Exclusion Criteria

1. Prior TAVI valve-in-valve procedures
2. Prior TAVI-in-TAVI procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVI	TAVI	-

Primary Outcome Measures

Name	Time	Method
PCI device success	5 year

Secondary Outcome Measures

Name	Time	Method
Final TIMI flow	5 year
Incidence of procedural complications	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
Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion	5 year
Successful selective engagement of guiding catheter	5 year
Procedural mortality	5 year

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel