NCT05873816

The PROTEMBO Trial

Cerebral Protection in Transcatheter Aortic Valve Replacement: The PROTEMBO Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Protembis GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.

Detailed description

Subjects with severe symptomatic aortic stenosis undergoing TAVR will be able to participate. Participants will be randomized in a 2:1:1 fashion to either the ProtEmbo arm, the Sentinel arm, or the 'No device' arm. Enrolled subjects will undergo an MRI at baseline and at 36 hours ±12 hours, to evaluate any new cerebral lesions. Enrolled subjects will be followed for 30 days. The study aims to address: * whether the occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days is comparable between the ProtEmbo group and the hybrid control group. * whether the total new lesion volume in the brain assessed by diffusion weighted magnetic resonance images at 36 ±12 hours is comparable between the ProtEmbo group and the hybrid control group.

Conditions

• Severe Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	ProtEmbo - Cerebral Embolic Protection	Subjects will undergo TAVR following placement of the ProtEmbo cerebral embolic protection device.
DEVICE	Sentinel - Cerebral Embolic Protection	Subjects will undergo TAVR following placement of the Sentinel cerebral embolic protection device.

Timeline

• Start date: 2024-03-21
• Primary completion: 2025-10-18
• Completion: 2025-12-31
• First posted: 2023-05-24
• Last updated: 2026-01-09

Locations

20 sites across 3 countries: United States, Germany, Poland

Regulatory

• FDA-regulated device study