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.
Prospective, non-randomized, single arm, multi-center CE Mark trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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%).
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
All-cause mortality
Freedom from all-cause mortality
Time frame: 30 days
Procedural Device Performance
Device implant success defined as: Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20mmHg or peak aortic valve velocity \<3 m/sec, AND no moderate or severe AR)
Time frame: During the Procedure
Post-procedural Valve Performance
Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters: * Aortic valve area (AVA) * Aortic valve regurgitation (AR) * Aortic valve gradient (Mean and Peak)
Time frame: 14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Rate of Adverse Events
* All adverse events through the one (1) year follow up period * All Serious Adverse Events through the five (5) year follow up period * Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years
Time frame: Throughout the 5-year follow-up period, assessed annually at a minimum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.