N/A
Completed N=64
Study of Aortic Root Reimplantation Procedure
Ascending Aortic Aneurism · Aortic Valve Insufficiency
Source: ClinicalTrials.gov NCT01787604 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) — 88.2; 87.7 percentage of participants
Summary
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) |
88.2; 87.7 | — |
| SECONDARY Survival (Percentage, Kaplan-Meier) |
82.7; 84.6 | — |
Eligibility Criteria
Inclusion Criteria
- Aortic insufficiency 2+
- Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome)
- Good conditions of aortic cusps
Exclusion Criteria
- Aortic annulus more than 32 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Data sourced from ClinicalTrials.gov (NCT01787604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.