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Study of New Predictors and Short Term Outcomes of Paravalvular Leakage After Transcatheter Aortic Valve Implanation

NCT03424902 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-07-08

No results posted yet for this study

Summary

The presence of aortic regurgitation (AR) jet from the aorta into the left ventricle is the most common complication after TAVI, occurring in about 70% of patients but usually trivial or mild (4, 5). In most previous studies, mild AR was not associated with a significantly shorter survival time (4, 5); however, the PARTNER trial demonstrated that it may be associated with worse long-term prognosis (3).

Significant AR (moderate and severe) is less common, occurring in approximately 15-20% of cases(6), and is considered one of the most important prognostic factors of mortality during short- and long-term follow-up (7, 8). It is, therefore, essential to understand the mechanisms and risk factors associated with the occurrence of AR in order to minimize its incidence .

Significant PVL most commonly results from(9):

1. Incomplete prosthesis apposition to the native annulus due to calcification or annular eccentricity
2. undersizing of the device and/or
3. malpositioning of the valve . These observations seem to be true for both balloon-expandable and self-expandable THVs.

However there are some new predictors which may correlate to occurance of paravalvular leakage including :

1. Eccentricity of aortic valve calcification.
2. Characterization of aortic annular calcification.
3. Associated mitral annular calcification.
4. Angle of LVOT to ascending aorta measurement (LVOT-AO).
5. The depth of implantation of valve in relation to aortic cusps.

Conditions

  • Paravalvular Leakage After TAVI

Interventions

DIAGNOSTIC_TEST

cardiac computed tomography and cardiac catheterization

assesment of certain predictors with CT and fluroscopy for paravalvular leakage

Sponsors & Collaborators

  • Marwan Sayed Mahmoud

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2020-12-01
Completion
2021-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424902 on ClinicalTrials.gov