Trial Outcomes & Findings for Study of Aortic Root Reimplantation Procedure (NCT NCT01787604)

NCT ID: NCT01787604

Last Updated: 2019-06-10

Results Overview

Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: up to 4 yeras
• Results posted on: 2019-06-10

Participant Flow

Participant milestones

Measure	Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Overall Study STARTED	32	32
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aortic Root Reimplantation Procedure n=32 Participants Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure n=32 Participants Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I	Total n=64 Participants Total of all reporting groups
Age, Continuous	59 years n=32 Participants	56 years n=32 Participants	58 years n=64 Participants
Sex: Female, Male Female	7 Participants n=32 Participants	7 Participants n=32 Participants	14 Participants n=64 Participants
Sex: Female, Male Male	25 Participants n=32 Participants	25 Participants n=32 Participants	50 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	32 Participants n=32 Participants	32 Participants n=32 Participants	64 Participants n=64 Participants

PRIMARY outcome

Timeframe: 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..

Outcome measures

Measure	Aortic Root Reimplantation Procedure n=32 Participants Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure n=32 Participants Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)	88.2 percentage of participants	87.7 percentage of participants

SECONDARY outcome

Timeframe: up to 4 yeras

Estimated percentage of alive participants for 4 years after treatment.

Outcome measures

Measure	Aortic Root Reimplantation Procedure n=32 Participants Aortic Root Reimplantation Procedure Aortic Root Reimplantation Procedure: Modified Florida Sleeve.	Aortic Valve Reimplantation Procedure n=32 Participants Aortic Valve Reimplantation Procedure Aortic Valve Reimplantation Procedure: David I
Survival (Percentage, Kaplan-Meier)	82.7 percentage of participants	84.6 percentage of participants

Adverse Events

Aortic Root Reimplantation Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Aortic Valve Reimplantation Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dmitry

MeshalkinRI

Phone: +79069090505

Email: dmhvan@mail.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place