HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
NCT02157142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2021-04-29
Summary
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
Conditions
- Severe Aortic Stenosis
- Aortic Valve Stenosis
Interventions
- DEVICE
-
HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
Sponsors & Collaborators
-
HLT Inc.
lead INDUSTRY
Principal Investigators
-
Axel Linke, MD · University of Leipzig - Herzzcntrum
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2014-12-31
- Completion
- 2019-10-31
- FDA Device
- Yes
Countries
- Germany
Study Locations
More Related Trials
-
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
NCT02162069 ·Status: COMPLETED ·Phase: NA
-
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
NCT02434263 ·Status: UNKNOWN ·Phase: NA
-
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
NCT03863132 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
NCT06721676 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement
NCT01675440 ·Status: COMPLETED
-
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
NCT05133843 ·Status: RECRUITING ·Phase: NA
-
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
NCT03112980 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Comparison of a Single Versus Double Perclose Technique for TAVR
NCT06173115 ·Status: RECRUITING ·Phase: NA
-
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
NCT01845285 ·Status: UNKNOWN
-
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
NCT07215143 ·Status: NOT_YET_RECRUITING
-
Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
NCT06472934 ·Status: RECRUITING ·Phase: NA
-
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
NCT02559011 ·Status: COMPLETED
-
Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement
NCT04489914 ·Status: COMPLETED
-
Impact of Predilatation Between Self-expanding Valves
NCT04157920 ·Status: COMPLETED ·Phase: NA
-
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
NCT05886517 ·Status: RECRUITING ·Phase: NA
-
Transcatheter Aortic Valve Implantation in Western NORway
NCT04417829 ·Status: COMPLETED
-
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation.
NCT04009434 ·Status: UNKNOWN ·Phase: NA
-
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
NCT07205341 ·Status: RECRUITING
-
Evaluation of BAV in Different Hemodynamic Entities of Severe AS
NCT04053192 ·Status: COMPLETED
-
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
NCT02701283 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
NCT04029363 ·Status: RECRUITING ·Phase: NA
-
NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis
NCT03287856 ·Status: COMPLETED ·Phase: NA
-
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
NCT03163329 ·Status: UNKNOWN ·Phase: PHASE2
-
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
NCT01445171 ·Status: COMPLETED ·Phase: NA
-
Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve
NCT04500964 ·Status: COMPLETED