Clinical trials: Aorta Disease
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Aneurysm Abdominal
Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms
This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm.
- Trial name
- RegisTREO (NCT06893952)
- Testing
- TREO Endograft
- Volunteers
- 209 people
- Sponsor
- Vascutek Ltd.
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
Guo's Visceral Arteries Reconstruction: First in Man Study
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
- Trial name
- NCT04731636
- Testing
- Thoracoabdominal aortic stent system
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Takayasu Arteritis (TAK)
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.
- Trial name
- SELECT-TAK (NCT04161898)
- Testing
- Upadacitinib, Prednisolone
- Where
- 48 sites in Argentina, Brazil and 4 more
- Volunteers
- 56 people
- Sponsor
- AbbVie
Aortic Valve Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme…
- Trial name
- NCT02746809
- Testing
- CoreValve Evolut 34R TAVR system
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Medtronic Cardiovascular
Aortic Dissection
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
- Trial name
- NCT05965271
- Testing
- Fabulous Thoracic Aortic Stent System
- Where
- 7 sites in China
- Volunteers
- 260 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
Cardiomyopathy, Hypertrophic Obstructive
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years.
- Trial name
- NCT04418297
- Testing
- CT-G20
- Where
- 11 sites in United States, Poland and 1 more
- Volunteers
- 23 people
- Sponsor
- Celltrion
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis, Transcatheter Aortic Valve Replacemen
Alwide Plus China Post-market Clinical Investigation
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve…
- Trial name
- NCT07304427
- Where
- 4 sites in China
- Volunteers
- 75 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Disease, Ascending Aorta Abnormality
Valved Graft PMCF Study
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
- Conditions
- Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection
- Trial name
- NCT04754217
- Testing
- VAVGJ, CAVGJ
- Where
- 25 sites in United States, Austria and 8 more
- Volunteers
- 260 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
To evaluate the safety and effectiveness of the TaurusNXT™ transcatheter aortic valve system in a patient population with symptomatic severe AS requiring replacement/repair of their native aortic valve that are at high risk for…
- Trial name
- NCT07908225
- Testing
- TAVR
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
Cardiomyopathy, Hypertrophic Obstructive
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- LIONHEART-HCM (NCT07755904)
- Testing
- BHB-1893, Metoprolol
- Where
- 3 sites in United States
- Volunteers
- 210 people
- Sponsor
- Braveheart Bio, Inc.
Aortic Stenosis, Severe
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic…
- Trial name
- NCT05989074
- Testing
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- Volunteers
- 130 people
- Sponsor
- Ceric Sàrl
Hypertrophic Cardiomyopathy With Obstruction
Triple Chamber Pacing in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients - TRICHAMPION STUDY
This investigation is a prospective, randomized, single-blinded and multicenter design. The purpose of this study is to evaluate the benefit of atrial-synchronous biventricular (BiV) pacing in severely symptomatic hypertrophic…
- Trial name
- TRICHAMPION (NCT01614717)
- Testing
- CRT-P Implant
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Diseases, Aortic Diseases
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement…
- Conditions
- Carotid Artery Diseases, Aortic Diseases, Peripheral Arterial Diseases
- Trial name
- NCT07322913
- Testing
- Intergard Standard - Collagen Coated Vascular Grafts and Patches, Hemashield - Collagen Coated Vascular Grafts and Patches, Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches
- Where
- 5 sites in United States, Belgium and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Intervascular
Aortic Valve Stenosis
RESPOND EDGE Post Market Study
The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially…
- Trial name
- RESPOND EDGE (NCT04009720)
- Testing
- Lotus Edge Device
- Where
- 13 sites in Denmark, Finland and 7 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better…
- Trial name
- NCT06094127
- Testing
- Endovascular aortic treatment
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Cook Research Incorporated