Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-up

Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-up - SURTAVI Trial 10 Year Follow-up

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45149

Enrollment

160

Registered

2012-05-01

Start date

2012-07-18

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

severe aortic valve stenosis

Interventions

General Procedural Considerations (TAVI) Transcatheter Aortic Valve Implantation (TAVI) requires meticulous preparation and typically a multi-disciplinary team approach involving among others, inte

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All subjects currently enrolled in the randomized cohort of the SURTAVI trial are eligible to consent to 10 year follow-up.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The primary objective of the 10 Year follow-up study is prospectively evaluate all-cause mortality or disabling stroke annually up to 10 years between TAVI (Transcatheter Aortic Valve Implantation) and SAVR (Surgical Aortic Valve Replacement).	—

Secondary

Measure	Time frame
The following secondary endpoints will be compared between MCS TAVI and SAVR subject cohorts: 1. MACCE event rates annually up to 10 years 2. Individual MACCE components annually up to 10 years 3. MAE event rates annually up to 10 years 4. Conduction disturbance requiring permanent pacemaker implantation annually up to 10 years 5. Change in NYHA class from baseline annually up to 5 years, 7 and 10 years 6. Echocardiographic assessment of prosthetic valve performance annually up to 5 years, 7 and 10 years using the following measures: • Transvalvular mean gradient • Effective orifice area • Degree of prosthetic aortic valve regurgitation (transvalvular and paravalvular) 7. Aortic valve disease related hospitalizations annually up to 10 years 8. Cardiovascular deaths and valve-related deaths annually up to 10 years 9. Strokes and TIAs 10. Evidence of prosthetic valve dysfunction annually up to 10 years	—

Measure

Time frame

The following secondary endpoints will be compared between MCS TAVI and SAVR subject cohorts: 1. MACCE event rates annually up to 10 years 2. Individual MACCE components annually up to 10 years 3. MAE event rates annually up to 10 years 4. Conduction disturbance requiring permanent pacemaker implantation annually up to 10 years 5. Change in NYHA class from baseline annually up to 5 years, 7 and 10 years 6. Echocardiographic assessment of prosthetic valve performance annually up to 5 years, 7 and 10 years using the following measures: • Transvalvular mean gradient • Effective orifice area • Degree of prosthetic aortic valve regurgitation (transvalvular and paravalvular) 7. Aortic valve disease related hospitalizations annually up to 10 years 8. Cardiovascular deaths and valve-related deaths annually up to 10 years 9. Strokes and TIAs 10. Evidence of prosthetic valve dysfunction annually up to 10 years

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)