Clinical trials: Aorta Disease
Severe Aortic Valve Stenosis
The PROTEMBO Trial
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and…
- Trial name
- NCT05873816
- Testing
- ProtEmbo - Cerebral Embolic Protection, Sentinel - Cerebral Embolic Protection
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 284 people
- Sponsor
- Protembis GmbH
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Trifecta™ Long Term Follow-Up (LTFU) Study
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of…
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT01593917
- Testing
- Trifecta™ Valve
- Where
- 11 sites in United States, Canada
- Volunteers
- 329 people
- Sponsor
- Abbott Medical Devices
Diastolic Heart Failure NYHA Class III-IV, Diastolic Dysfunction Secondary to Aortic Stenosis
CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction
The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".
- Trial name
- NCT01956526
- Testing
- CORolla™ TAA device
- Where
- 2 sites in Italy
- Volunteers
- 12 people
- Sponsor
- CorAssist Cadiovascular Ltd.
Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched…
- Trial name
- EMBRACE (NCT05143138)
- Testing
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Where
- 14 sites in Denmark, Italy and 4 more
- Volunteers
- 259 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysms
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.
- Trial name
- NCT00604643
- Testing
- TALENT Aortic Cuff Abdominal Stent Graft
- Where
- 50 sites in United States
- Sponsor
- Medtronic Cardiovascular
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
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
- Trial name
- AAA-SHAPE_NLD (NCT04751578)
- Testing
- IMPEDE-FX Embolization Plug
- Where
- 3 sites in Netherlands
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
Aortic Valve Disease
KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
- Trial name
- KONECTION (NCT07619872)
- Testing
- Edwards KONECT RESILIA AVC
- Where
- 3 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
Avalus Ultra Post-Approval Study (PAS)
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
- Trial name
- NCT06506903
- Testing
- Medtronic Avalus Ultra
- Where
- 15 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Stenosis
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe…
- Trial name
- NCT02903420
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 2 sites in Japan
- Volunteers
- 38 people
- Sponsor
- Edwards Lifesciences
Abdominal Aortic Aneurysm
Nectero EAST System Clinical Study
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment.
- Trial name
- stAAAble (NCT06001918)
- Testing
- Nectero EAST System
- Where
- 42 sites in United States, Australia and 1 more
- Volunteers
- 400 people
- Sponsor
- Nectero Medical, Inc.
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Aortic Diseases
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.
- Trial name
- ADSORB (NCT00742274)
- Testing
- Gore TAG Endoprosthesis, Best Medical Therapy
- Volunteers
- 61 people
- Sponsor
- W.L.Gore & Associates
Aortic Valve Stenosis
The Leaflex™ Brazilian Standalone Study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
- Trial name
- NCT05052684
- Testing
- Leaflex™ Performer
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Pi-cardia
Heart Valve Diseases
Clinical Investigation of the Freedom SOLO Stentless Heart Valve
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Trial name
- NCT00876525
- Testing
- Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 702 people
- Sponsor
- Corcym S.r.l