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 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-05-04
Summary
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
Conditions
- Aortic Valve Stenosis
Interventions
- DEVICE
-
TAVR
Repair of defective aortic valve by microsurgical Intervention.
Sponsors & Collaborators
-
Boston Scientific Group
collaborator UNKNOWN -
Yale University
collaborator OTHER -
IHF GmbH - Institut für Herzinfarktforschung
lead OTHER
Principal Investigators
-
Julinda Mehilli, Prof. Dr. · University Clinic Munich
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-03
- Primary Completion
- 2027-09-01
- Completion
- 2028-03-01
Countries
- Germany
Study Locations
More Related Trials
-
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
NCT03633383 ·Status: UNKNOWN
-
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
NCT04385459 ·Status: COMPLETED
-
Aortic Stenosis - Prognosis, Risk and Outcomes
NCT06863883 ·Status: NOT_YET_RECRUITING
-
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
NCT02559011 ·Status: COMPLETED
-
PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
NCT05539573 ·Status: ACTIVE_NOT_RECRUITING
-
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).
NCT02210351 ·Status: UNKNOWN ·Phase: NA
-
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
NCT04827238 ·Status: COMPLETED
-
Observational Study to Collect Data of Patient Which Recieving a TAVI in TAVI Procedure
NCT07215143 ·Status: NOT_YET_RECRUITING
-
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
NCT03667365 ·Status: TERMINATED ·Phase: NA
-
DEFLECT I: Keystone Heart Embolic Deflection Trial
NCT01448421 ·Status: COMPLETED ·Phase: NA
-
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
NCT02628899 ·Status: COMPLETED ·Phase: NA
-
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
NCT02950428 ·Status: COMPLETED ·Phase: NA
-
Coronary Artery Disease Assessment Strategies in TAVI Patients
NCT06559332 ·Status: RECRUITING ·Phase: NA
-
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
NCT06212050 ·Status: ENROLLING_BY_INVITATION
-
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
NCT06777368 ·Status: RECRUITING
-
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
-
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
NCT03163329 ·Status: UNKNOWN ·Phase: PHASE2
-
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
NCT06154642 ·Status: COMPLETED
-
Aortic Root Enlargement in Aortic Valve Replacement
NCT03603483 ·Status: UNKNOWN ·Phase: NA
-
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
NCT03836521 ·Status: RECRUITING
-
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
NCT01700439 ·Status: COMPLETED ·Phase: NA
-
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
NCT05708118 ·Status: UNKNOWN
-
A Prospective, Multicenter, Observational Study of the Safety and Efficacy of Emergency Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis
NCT07108478 ·Status: NOT_YET_RECRUITING
-
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
NCT06679517 ·Status: ENROLLING_BY_INVITATION