Clinical trials: Aorta Disease
Abdominal Aortic Aneurysm
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03687489
- Testing
- Abdominal Aortic Aneurysm Stent Graft System
- Where
- 22 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM)
Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM), Non-obstructive HCM (nHCM)
- Trial name
- NCT07675668
- Testing
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID), QG101-23-0 enteric coated capsule (120/240/360/480mg BID)
- Volunteers
- 56 people
- Sponsor
- Amckaus PTY LTD.
AAA - Abdominal Aortic Aneurysm
Endurant CHevAr New Indication Trial: ENCHANT
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for…
- Trial name
- ENCHANT (NCT03320252)
- Testing
- Endurant Chimney Graft Technique
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Trial name
- GALILEO-4D (NCT02833948)
- Testing
- Acetylsalicylic acid, Clopidogrel, Rivaroxaban
- Where
- 25 sites in United States, Canada and 5 more
- Volunteers
- 231 people
- Sponsor
- ECRI bv
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 Cardiomyopathy, Nonsustained Ventricular Tachycardia
Extended ECG Monitoring in HCM Patients
The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc.
- Conditions
- Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia, Ventricular Tachycardia, Atrial Fibrillation
- Trial name
- EXAMINE-HCM (NCT04056715)
- Testing
- Zio XT
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- iRhythm Technologies, Inc.
Murmur, Heart, Aortic Valve Stenosis
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML…
- Conditions
- Murmur, Heart, Aortic Valve Stenosis, Tricuspid Regurgitation, Mitral Regurgitation
- Trial name
- NCT04400513
- Testing
- Use of Eko CORE and Eko DUO electronic stethoscopes
- Where
- United States
- Volunteers
- 1,145 people
- Sponsor
- Eko Devices, Inc.
Abdominal Aortic Aneurysm, Endoleak
ANEUFIX for Endoleak Type II Repair
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR…
- Trial name
- NCT03918460
- Testing
- ANEUFIX
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- TripleMed B.V.
Postpartum Hemorrhage
Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
This multicenter study aims to evaluate effectiveness and safety of using the AAJT-S device as a temporary intervention for severe, atony-related PPH that is refractory to standard therapies
- Trial name
- ACT-PPH (NCT07034924)
- Testing
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Where
- Ukraine
- Volunteers
- 20 people
- Sponsor
- LLC UkrMedGroup
Abdominal Aortic Aneurysm
Global Fenestrated Anaconda Clinical STudy
This study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study.
- Trial name
- Global FACT (NCT03180996)
- Testing
- Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 160 people
- Sponsor
- Vascutek Ltd.
Aortic Valve Stenosis, Aortic Valve Disease
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
- Trial name
- NCT05295628
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
- Where
- 23 sites in United States
- Volunteers
- 532 people
- Sponsor
- Emblok, Inc.
Abdominal Aortic Aneurysms
China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring…
- Trial name
- NCT03965364
- Testing
- INCRAFT
- Where
- China
- Sponsor
- Cordis US Corp.
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Heart Valve Diseases
Medtronic HAMMOCK Post Approval Study
This study is being conducted to satisfy the post-CE approval requirement.
- Trial name
- NCT03139721
- Testing
- Mosaic model 305, model 310, and ultra model 305
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 122 people
- Sponsor
- Medtronic Cardiac Surgery
Heart Valve Diseases
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00630916
- Testing
- Mitroflow Aortic Heart Valve
- Where
- 26 sites in United States, Canada
- Volunteers
- 756 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Disease, Cardiovascular Diseases
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
- Trial name
- METASAR (NCT05941455)
- Testing
- Venus-Neo Surgical Aortic Valve
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Jilin Venus Haoyue Medtech Limited
Aortic Stenosis, Severe
China S3 PMS: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
- Trial name
- NCT05168826
- Testing
- SAPIEN 3 Transcatheter Heart Valve
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Vascular Ehlers-Danlos Syndrome
Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.
- Trial name
- DiSCOVER (NCT05432466)
- Testing
- ACER-002 (celiprolol) 200 mg BID
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Acer Therapeutics Inc.
Aortoiliac Occlusive Disease
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use…
- Trial name
- NCT06872905
- Testing
- GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
- Where
- 27 sites in United States, Italy and 3 more
- Volunteers
- 158 people
- Sponsor
- W.L.Gore & Associates
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.