Post-TAVI Coronary Access Study

NCT ID: NCT04649190

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2023-06-01

Brief Summary

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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

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Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TAVI

TAVI

Intervention Type DEVICE

Coronary access for PCI after TAVI

Interventions

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TAVI

Coronary access for PCI after TAVI

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Issi Barbash

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-13-0685-IB-CTIL-B

Identifier Type: -

Identifier Source: org_study_id

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