NCT04372381

Supra-Annular vs. Annular ValvEs for Small Annuli

Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Marvin Eng · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Detailed description

Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.

Conditions

• Aortic Valve Stenosis
• Implantation, Heart Valve Prosthesis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro	Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Timeline

• Start date: 2020-05-12
• Primary completion: 2024-11-01
• Completion: 2025-06-01
• First posted: 2020-05-04
• Last updated: 2023-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study