Clinical trials: Coronary Stenosis
Aortic Valve Stenosis
Transfemoral Implant of Inovare® Transcatheter Valve
Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.
- Trial name
- NCT05531578
- Testing
- INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)
- Where
- 4 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Valve Stenosis
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures.
- Trial name
- PostCorE (NCT02472106)
- Testing
- Post-dilatation
- Volunteers
- 9 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis Symptomatic
Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis
A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical
- Trial name
- NCT06721676
- Testing
- transcatheter aortic valve replacement in severe aortic stenosis
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Coronary Arteriosclerosis
Scoreflex TRIO - Scoring PTCA Catheter
To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary…
- Trial name
- NCT05929313
- Testing
- OrbusNeich Scoreflex TRIO, OrbusNeich Scoreflex NC
- Where
- 4 sites in China
- Volunteers
- 210 people
- Sponsor
- OrbusNeich
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
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.
Coronary Disease
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch…
- Trial name
- BIPAX (NCT01308229)
- Testing
- Nile PAX® paclitaxel-eluting coronary stent
- Where
- 10 sites in Brazil, Bulgaria and 5 more
- Volunteers
- 102 people
- Sponsor
- MINVASYS
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Aortic Stenosis
ACURATE TA™ Valve Implantation Registry: SAVI 2
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to…
- Trial name
- TA-SAVI2 (NCT02663375)
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 27 sites in Austria, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
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
Aortic Stenosis, Aortic Regurgitation
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and…
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Hypertension, LVM
- Trial name
- NCT03666351
- Testing
- Amlodipine 5mg, Losartan, Losartan and Amlodipine
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Coronary Artery Stenosis
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare…
- Trial name
- BLAST (NCT00739466)
- Testing
- Liposomal Alendronate
- Where
- 12 sites in Israel
- Volunteers
- 226 people
- Sponsor
- BIOrest Ltd.
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Cardiovascular Disease
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
To assess the clinical value of iFR to characterize, without concomitant administration of hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as determined with fractional flow reserve (FFR)
- Trial name
- ADVISEII (NCT01740895)
- Where
- 44 sites in United States, Canada and 6 more
- Volunteers
- 818 people
- Sponsor
- Volcano Corporation
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Real-World Effectiveness of Mavacamten in Canada
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM)…
- Trial name
- MAVEN (NCT06338202)
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Cardiomyopathy
VIZ ACCESS HCM - Multi-Site Registry
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM.
- Trial name
- NCT07103057
- Testing
- Viz HCM
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Viz.ai, Inc.
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.