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Valvular & structural heart diseaseCohort study

Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study

LancetPublished

  • Prospective single-arm study
  • multicentre
  • investigational device exemption
  • pivotal + continued-access cohort
  • 30 US centres
  • Median follow-up 472 days (IQR 352-891)
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Authors' conclusion

In patients with symptomatic moderate-to-severe or severe aortic regurgitation considered to be of high surgical risk, TAVI with a dedicated platform met prespecified safety and effectiveness performance goals.

Study context

Population
Patients at high surgical risk with symptomatic moderate-to-severe or severe native aortic regurgitationpivotal n=180
Participants
700 patients
Exposure
Transcatheter aortic valve intervention (TAVI) with Trilogy valve vs performance goals
  • Trilogy valven = 700
Outcome
Coprimary: 30-day safety composite of major adverse events (all-cause death, stroke, life-threatening or major bleeding, AKI, major vascular complications, additional surgical or percutaneous intervention, new pacemaker, moderate or greater aortic regurgitation; non-inferiority vs performance goal 40.5%) and 1-year all-cause mortality (superiority vs performance goal 25.0%)
Follow-up
30 days; 1 year

Main finding

As reported in the abstract

Coprimary: 30-day safety composite of major adverse events; 1-year all-cause mortality

30-day primary safety composite endpoint, met the performance goal of 40.5% (pnon-inferiority<0.0001)

168 (24.0% [upper 97.5% CI 27.3%])

1-year all-cause mortality, met the performance goal of 25.0% (psuperiority<0.0001)

38 (7.7% [upper 97.5% CI 10.4%])

Observational data: associations, not effects.

Further findings

Technical success

Technical success
664 (95%)

All-cause mortality · up to 2 years

All-cause mortality at 2 years
53 (13.3%)

Safety

Components of the 30-day safety composite

Death
11 (1.6%)
Stroke
12 (1.7%)
New pacemaker implantation
127 (21.6%) of 589
Moderate aortic regurgitation
3 (0.5%) of 569
Severe aortic regurgitation
0

Original publication

Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. Published 16 November 2025. doi:10.1016/s0140-6736(25)02215-9
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Summarised from the published abstract; every number is checked against it