Clinical trials: Aortic Diseases
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Iliac Aneurysm, Aortic Aneurysm
Cook Iliac Branch Graft Post-market Registry
The Cook Iliac Branch Graft Post-market Registry will obtain case reports of physician experience with a CE-marked Cook Iliac Branch Graft to further confirm device safety and performance.
- Trial name
- NCT01055275
- Testing
- Implantation with a Cook Iliac Branch Graft
- Where
- Spain
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
Aortic Valve Stenosis
Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
- Trial name
- NCT01475799
- Testing
- Replacement of the Aortic Stenotic Valve
- Where
- 12 sites in France, Germany and 3 more
- Volunteers
- 112 people
- Sponsor
- Direct Flow Medical, Inc.
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
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
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.
Thoracoabdominal Aortic Aneurysm
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch Stent Graft System (INNER-B-APAC)
The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with…
- Trial name
- NCT05954793
- Where
- 8 sites in Australia, New Zealand and 1 more
- Volunteers
- 16 people
- Sponsor
- JOTEC GmbH
Aortic Valve Disease, Aortic Valve Stenosis
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure
- Trial name
- NCT04142658
- Testing
- Apixaban 5 MG, Apixaban 2.5 MG, Warfarin
- Where
- 62 sites in United States
- Volunteers
- 863 people
- Sponsor
- Artivion Inc.
Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during…
- Trial name
- NCT07648693
- Testing
- CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System
- Where
- 15 sites in China
- Volunteers
- 240 people
- Sponsor
- Resonova (Shanghai) Medtech Limited
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Aortic Arch Aneurysm, Penetrating Aortic Ulcer
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
- Trial name
- NCT06520774
- Testing
- Concave Supra-arch Branched Stent-Graft System
- Where
- 17 sites in China, Germany
- Volunteers
- 103 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aortic Aneurysm, Thoracoabdominal
Post-market Observational Study Zenith® t-Branch™
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
- Trial name
- NCT02104089
- Testing
- Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Where
- 3 sites in Germany, Sweden
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
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.
Abdominal Aortic Aneurysms
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac…
- Trial name
- PYTHAGORAS (NCT00522535)
- Testing
- Open surgical repair, Stent Graft
- Where
- 38 sites in United States
- Volunteers
- 230 people
- Sponsor
- Lombard Medical
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.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician…
- Trial name
- SPARC-HCM (NCT07557498)
- Testing
- Mavacamten
- Where
- United Kingdom
- Volunteers
- 362 people
- Sponsor
- Bristol-Myers Squibb
Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
Pilot Study of the Endologix Fenestrated Stent Graft System
The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
- Trial name
- NCT01437215
- Testing
- Ventana Fenestrated Stent Graft System
- Where
- 2 sites in Chile, New Zealand
- Volunteers
- 15 people
- Sponsor
- Endologix
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
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Hypertension
Changes in Endothelial Function and Biomarkers in African Americans (AA) With Metabolic Syndrome
The purpose of the study is to compare the effects of Azor (a combination of amlodipine and olmesartan) with Hyzaar ( a combination of losartan and hydrochlorothiazide) on the thin lining on the inside of blood vessels.
- Trial name
- AMORE (NCT01271374)
- Testing
- amlodipine and olmesartan, losartan and HCTZ
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- InVasc Therapeutics, Inc.