Clinical trials: Aortic Insufficiency
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Stenosis, Aortic Regurgitation
Mitroflow DL Post Approval Study- North America
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases
- Trial name
- NCT02351726
- Testing
- Mitroflow DL
- Where
- 13 sites in United States
- Volunteers
- 186 people
- Sponsor
- LivaNova
Heart Septal Defects, Ventricular, Aortic Valve Insufficiency
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age.
- Trial name
- NCT00173186
- Where
- Taiwan
- Volunteers
- 411 people
- Sponsor
- National Taiwan University Hospital
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Aortic Stenosis, Aortic Insufficiency
CardioCel Tri-leaflet Repair Study
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
- Trial name
- CTRS (NCT02629328)
- Testing
- CardioCel
- Where
- Belgium
- Volunteers
- 28 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis, Aortic Valve Insufficiency
CryoValve® SG Aortic Human Heart Valve Combination Study
The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.
- Trial name
- SGAV (NCT01236469)
- Testing
- Echocardiogram
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- CryoLife, Inc.
Aortic Regurgitation
Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.
- Trial name
- NCT05332184
- Testing
- aortic valve surgery
- Volunteers
- 40 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Surgery, Postoperative Acute Kidney Injury
Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach
Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed.
- Trial name
- NCT01844219
- Testing
- elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)
- Where
- South Korea
- Volunteers
- 375 people
- Sponsor
- Samsung Medical Center
Aortic Stenosis, Mitral Regurgitation
Evaluating Infrasonic Hemodynography
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
- Conditions
- Aortic Stenosis, Mitral Regurgitation, Pulmonary Hypertension, Heart Failure, Systolic
- Trial name
- NCT04636892
- Testing
- MindMics earbud
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Scripps Health
Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
- Conditions
- Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency, Aortic Valve Stenosis, Aortic Valve Insufficiency
- Trial name
- SGPV (NCT01092442)
- Testing
- Echocardiogram
- Where
- 8 sites in United States
- Volunteers
- 140 people
- Sponsor
- CryoLife, Inc.
Congenital Disorders
Incidence of Neo-Aortic Insufficiency
The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated.
- Trial name
- NCT00268073
- Where
- United States
- Sponsor
- Children's Healthcare of Atlanta
Aortic Valve Disease, Chronic Kidney Disease
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI).
- Conditions
- Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury
- Trial name
- PANTER (NCT03121053)
- Testing
- sodium bicarbonate, hypotone saline
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- St. Antonius Hospital
Aortic Root Aneurysm, Aortic Regurgitation
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six…
- Trial name
- AORTLANTIC (NCT05515848)
- Testing
- No intervention
- Where
- 5 sites in France
- Volunteers
- 529 people
- Sponsor
- Nantes University Hospital
Aortic Valve Disease, Aortic Valve Insufficiency
J-Valve TF Early Feasibility Study
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to…
- Conditions
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation
- Trial name
- JVTF EFS (NCT06034028)
- Testing
- J-Valve TF System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05957419
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Kidney Transplant, Familial Hypercholesterolaemia
Cardiovascular Risk in Children With Chronic Conditions Study
Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels.
- Conditions
- Kidney Transplant, Familial Hypercholesterolaemia, Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM)
- Trial name
- CR3C (NCT07086989)
- Where
- 3 sites in Hungary
- Volunteers
- 300 people
- Sponsor
- Semmelweis University
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05332691
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei