Aortic Valve Insufficiency, Ascending Aortic Aneurism
Conditions
Keywords
Valve-sparing, Valve repair
Brief summary
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Detailed description
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.
Interventions
PROCEDUREAortic Root Reimplantation Procedure
Modified Florida Sleeve.
PROCEDUREAortic Valve Reimplantation Procedure
David I
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | up to 4 yeras | Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival (Percentage, Kaplan-Meier) | up to 4 yeras | Estimated percentage of alive participants for 4 years after treatment. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure
Aortic Root Reimplantation Procedure: Modified Florida Sleeve. | 32 |
| Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure
Aortic Valve Reimplantation Procedure: David I | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Aortic Valve Reimplantation Procedure | Total | Aortic Root Reimplantation Procedure |
|---|---|---|---|
| Age, Continuous | 56 years | 58 years | 59 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Male | 25 Participants | 50 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 32 | 4 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
Time frame: up to 4 yeras
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Root Reimplantation Procedure | Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | 88.2 percentage of participants |
| Aortic Valve Reimplantation Procedure | Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | 87.7 percentage of participants |
Secondary
Survival (Percentage, Kaplan-Meier)
Estimated percentage of alive participants for 4 years after treatment.
Time frame: up to 4 yeras
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aortic Root Reimplantation Procedure | Survival (Percentage, Kaplan-Meier) | 82.7 percentage of participants |
| Aortic Valve Reimplantation Procedure | Survival (Percentage, Kaplan-Meier) | 84.6 percentage of participants |