SOURCE ANZ - An observational study using registry data to assess safety and efficacy outcomes data in patients with diagnosed Aortic Valve Stenosis who may be eligible for replacing the aortic heart valve without the need for open heart surgery

Edwards SAPIEN Transcatheter Heart Valve Australian and New Zealand SOURCE Registry: A multi-centre Observational Registry of Percutaneous Aortic Valve Replacement (PAVR) using the Edwards SAPIEN Transcatheter Heart Valve to collect the safety and efficacy outcomes data.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611001026910

Acronym

SOURCE

Enrollment

133

Registered

2011-09-27

Start date

2008-12-08

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Patients with severe Aortic Stenosis may be eligible for the insertion of a biological heart valve implanted percutaneously via the transfemoral or transapical route then balloon expanded once in the aortic valve position. The SOURCE registry is a database documenting patient outcomes at 30 days and 12 months post procedure. The data extracted measures procedure success and quality of life improvement. Also measured are the major complications associated with the procedure and device.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key inclusion critieria – 1. Aortic valve area <0.8 cm2 2. Patients with symptomatic, severe calcific degenerative aortic stenosis requiring AVR, and considered to have high risk of operative mortality or is ‘non-operable’.

Exclusion criteria

Key Exclusion criteria – 1. Patients with non-valvular, non-calcific acquired or congenital aortic stenosis, with unicuspid or bicuspid aortic valve 2. Patients unsuitable for AVR via transfemoral or transapical approach

Outcome results