Balloon aortic valvuloplasty versus surgical aortic valvuloplasty for congenital aortic valve stenosis.

Non- randomized comparison mortality in patients receiving balloon aortic valvuloplasty versus surgical aortic valvuloplasty for congenital aortic valve stenosis, using propensity score matching.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618001180202

Enrollment

100

Registered

2018-07-17

Start date

2017-10-22

Completion date

2018-06-19

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Congenital aortic stenosis is a lifelong disease often requiring multiple interventions. Valvuloplasty refers to the procedure by which the valve obstruction is relieved by either incising the valve during a surgical procedure or utilising balloon to stretch the valve during an interventional cardiology procedure. We are seeking to determine the early and late outcomes of surgical or balloon aortic valvuloplasty and whether the technique use, influences the long term risk of re-intervention, other morbidities, or death.

Interventions

Data from children with congenital heart disease who have undergone balloon aortic valvuloplasty (Lady Cilento Children's Hospital, Royal Children's Hospital) between January 1st 2002 and December 31st 2016. Endpoints will be examined at 30 days (early outcomes) and 12 months (long-term outcomes) following intervention.

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

Patients who underwent balloon aortic valvuloplasty or surgical aortic valvuloplasty for congenital aortic valve stenosis between 2002 to 2016

Exclusion criteria

Patients with congenital AS who underwent univentricular repair, homograft valve replacement and Ross procedure, as their initial procedure.

Outcome results