N/A N=64 Randomized Single-blind Treatment

Study of Aortic Root Reimplantation Procedure

Ascending Aortic Aneurism · Aortic Valve Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01787604 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2019

Primary outcome: Primary: Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) — 88.2; 87.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aortic Root Reimplantation Procedure (Procedure); Aortic Valve Reimplantation Procedure (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Primary completion: Nov 2015

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	—

Summary

Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.

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

View full record on ClinicalTrials.gov →

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.