NCT03424902

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

Status unknown Last updated 8 July 2020

What this trial tests

trial testing cardiac computed tomography and cardiac catheterization in Paravalvular Leakage After TAVI in 100 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 December 2020

1 March 2021

Quick facts

Lead sponsor	Marwan Sayed Mahmoud
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	1 September 2020
Primary completion	1 December 2020
Estimated completion	1 March 2021

Drugs / interventions tested

• cardiac computed tomography and cardiac catheterization

Conditions studied

• Paravalvular Leakage After TAVI — all drugs for Paravalvular Leakage After TAVI →

Sponsor

Marwan Sayed Mahmoud

Who can join

Eligibility, any sex, with Paravalvular Leakage After TAVI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.