NCT03805711

HLT Meridian Valve CE Mark Trial

Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: HLT Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.

Detailed description

Prospective, non-randomized, single arm, multi-center CE Mark trial.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	HLT® Transcatheter System	Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).

Timeline

• Start date: 2019-07-12
• Primary completion: 2019-09-20
• Completion: 2019-09-20
• First posted: 2019-01-16
• Last updated: 2020-05-19

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study