NCT03633383

Brief Summary

TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

July 14, 2018

Last Update Submit

August 13, 2018

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    Causes of mortality such stroke, myocardial infarction, kidney injury,bleeding

    one month

Secondary Outcomes (8)

  • Stroke

    One month

  • Myocardial infarction

    One month after tavi

  • Bleeding

    One month after tavi

  • Hospital stay

    One month

  • Acute kidney injury

    One month

  • +3 more secondary outcomes

Study Arms (2)

Transfemoral Approach

Device: Transcatheter aortic valve

Transapical Approach

Device: Transcatheter aortic valve

Interventions

Transcatheter aortic valveDEVICE

Self-expandable aortic valve prothesis

Transapical ApproachTransfemoral Approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who meet the listed inclusion and exclusion criteria will be eligible for the study

You may qualify if:

  • Patients with severe symptomatic aortic stenosis undergoing TAVI.

You may not qualify if:

  • Patients with concomitant valvular heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Andersen HR, Knudsen LL, Hasenkam JM. Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs. Eur Heart J. 1992 May;13(5):704-8. doi: 10.1093/oxfordjournals.eurheartj.a060238.

    PMID: 1618213BACKGROUND

  • Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

    PMID: 12473543BACKGROUND

  • Rodes-Cabau J. Transcatheter aortic valve implantation: current and future approaches. Nat Rev Cardiol. 2011 Nov 15;9(1):15-29. doi: 10.1038/nrcardio.2011.164.

    PMID: 22083020BACKGROUND

  • Chow SC, Cheung GS, Lee AP, Wu EB, Ho JY, Kwok MW, Yu PS, Wan IY, Underwood MJ, Wong RH. Transcatheter aortic valve implantation: the transaortic approach. Asian Cardiovasc Thorac Ann. 2017 Jun;25(5):357-363. doi: 10.1177/0218492317702027. Epub 2017 May 17.

    PMID: 28513189BACKGROUND

  • Tamburino C, Capodanno D, Ramondo A, Petronio AS, Ettori F, Santoro G, Klugmann S, Bedogni F, Maisano F, Marzocchi A, Poli A, Antoniucci D, Napodano M, De Carlo M, Fiorina C, Ussia GP. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011 Jan 25;123(3):299-308. doi: 10.1161/CIRCULATIONAHA.110.946533. Epub 2011 Jan 10.

    PMID: 21220731BACKGROUND

  • Masson JB, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve implantation: review of the nature, management, and avoidance of procedural complications. JACC Cardiovasc Interv. 2009 Sep;2(9):811-20. doi: 10.1016/j.jcin.2009.07.005.

    PMID: 19778768BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Ahmed Ghoneim, Professor

    Assiut University

    STUDY CHAIR

  • Hussien Elkhayat, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Moustafa Mohamed

CONTACT

01002826100moustafaelbadry.90@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 14, 2018

First Posted

August 16, 2018

Study Start

August 31, 2018

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

August 16, 2018

Record last verified: 2018-08