NCT01787604

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2015

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

June 10, 2019

Completed
Last Updated

June 10, 2019

Status Verified

March 1, 2019

Enrollment Period

4.9 years

First QC Date

January 30, 2013

Results QC Date

September 7, 2017

Last Update Submit

March 10, 2019

Conditions

Ascending Aortic AneurismAortic Valve Insufficiency

Keywords

Valve-sparingValve repair

Outcome Measures

Primary Outcomes (1)

  • 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..

    up to 4 yeras

Secondary Outcomes (1)

  • Survival (Percentage, Kaplan-Meier)

    up to 4 yeras

Study Arms (2)

Aortic Root Reimplantation Procedure

ACTIVE COMPARATOR

Aortic Root Reimplantation Procedure

Procedure: Aortic Root Reimplantation Procedure

Aortic Valve Reimplantation Procedure

ACTIVE COMPARATOR

Aortic Valve Reimplantation Procedure

Procedure: Aortic Valve Reimplantation Procedure

Interventions

Aortic Root Reimplantation ProcedurePROCEDURE

Modified Florida Sleeve.

Also known as: Modified Florida Sleeve.
Aortic Root Reimplantation Procedure
Aortic Valve Reimplantation ProcedurePROCEDURE

David I

Also known as: David I
Aortic Valve Reimplantation Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Aortic annulus more than 32 mm
  • Aortic cusps destruction
  • Critical aortic cusps elongation
  • Aortic root dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meshalkin State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (2)

  • Alexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675

    RESULT

  • Чернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47

    RESULT

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dmitry
Organization
MeshalkinRI
dmhvan@mail.ru
+79069090505

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiac surgeon

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 8, 2013

Study Start

January 1, 2011

Primary Completion

November 20, 2015

Study Completion

November 20, 2015

Last Updated

June 10, 2019

Results First Posted

June 10, 2019

Record last verified: 2019-03

Locations

RU(1)