Clinical trials: Aortic Diseases
AAA, AAA - Abdominal Aortic Aneurysm
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population.
- Trial name
- JAGUAR (NCT05064540)
- Testing
- Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
- Where
- 29 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix
Aortic Valve Stenosis, Heart Valve Diseases
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)
Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female…
- Trial name
- RHEIA (NCT04160130)
- Testing
- Transcatheter aortic valve replacement
- Where
- 48 sites in Austria, Belgium and 10 more
- Volunteers
- 432 people
- Sponsor
- Optimapharm
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
- Trial name
- TTRACK (NCT03842163)
- Testing
- Diagnosis of TTR amyloidosis cardiomyopathy
- Where
- 18 sites in Australia, Austria and 8 more
- Volunteers
- 812 people
- Sponsor
- Pfizer
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
This is a decentralized, single-group, open-label clinical trial evaluating a 12-week regimen of the NeuEve Dryness Treatment Kit (comprising Feminine Moisture Support oral softgels, Bone Support oral capsules, NeuEve Salve…
- Conditions
- Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin), Improves Vaginal Wall Thickness, Reduces Pain During Sex
- Trial name
- NCT07893795
- Testing
- Intervention
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NeuEve
Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm
ANATOMICAL FEASIBILITY OF BRAILE STANDARD BRANCHED ENDOGRAFT
The objective of this retrospective observational study is to evaluate the theoretical anatomical suitability of the new Braile off-the-shelf multi-branched endograft in patients with thoracoabdominal aneurysm.
- Conditions
- Thoracoabdominal Aortic Aneurysm, Endovascular Repair of Aortic Aneurysm, Vascular Diseases, Aortic Diseases
- Trial name
- BMETA (NCT07118995)
- Testing
- Analysis of preoperative CTA
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Thoracic Aortic Dissection
Post-market Clinical Trial of the Dominus® Stent-Graft
Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
- Trial name
- DominusPMCF (NCT06270537)
- Testing
- Stent-Graft Dominus® Endoprosthesis
- Where
- 3 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Dissection
Study on the Aortic Arch Single Branch Stent Graft System
The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
- Trial name
- NCT06915545
- Testing
- Aortic Arch Single Branch Covered Stent System
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aortic Stenosis
ACURATE Prime XL Human Feasibility Study
To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.
- Trial name
- NCT05224245
- Testing
- ACURATE Prime XL Transfemoral Aortic Valve System
- Where
- 3 sites in Australia
- Volunteers
- 13 people
- Sponsor
- Boston Scientific Corporation
Danon Disease
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
This is a single arm Phase 2 trial to evaluate the efficacy and safety of RP-A501, a recombinant adeno-associated virus serotype 9 (rAAV9) vector containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B)…
- Trial name
- NCT06092034
- Testing
- RP-A501
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Abdominal Aortic Aneurysm
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels
To assess the safety and performance of Aorfix™ Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac…
- Trial name
- ARBITER-II (NCT00442065)
- Testing
- Aorfix™ Stent Grafts (AAA endovascular procedure)
- Where
- 6 sites in Czechia, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Lombard Medical
Abdominal Aortic Aneurysm
A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)
The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.
- Trial name
- INSPIRATION (NCT01664078)
- Testing
- Endovascular AAA repair with InCraft®
- Where
- 2 sites in United States, Japan
- Volunteers
- 190 people
- Sponsor
- Cordis US Corp.
ABDOMINAL AORTIC ANEURYSMS
The (PIVOTAL) Study
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture…
- Trial name
- NCT00444821
- Testing
- AneuRx AAA stent graft / Talent AAA stent graft
- Where
- 65 sites in United States
- Volunteers
- 728 people
- Sponsor
- Medtronic Cardiovascular
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Elective Cardiac Surgery
Pleiades Safety and Feasibility Study
The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing…
- Trial name
- NCT05662501
- Testing
- Pleioflow-RF
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Pleioflow
Abdominal Aortic Aneurysm
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
- Trial name
- NCT01491945
- Testing
- Ventana Fenestrated Stent Graft System
- Where
- 22 sites in United States
- Volunteers
- 76 people
- Sponsor
- Endologix
Abdominal Aortic Aneurysms
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest…
- Trial name
- ARCHYTAS (NCT02480595)
- Testing
- Stent Graft
- Where
- 37 sites in Czechia, Germany and 4 more
- Volunteers
- 500 people
- Sponsor
- Lombard Medical
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH