Clinical trials: Coronary; Obstruction
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
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
Atrioventricular Conduction Block
Micra Atrial TRacking Using A Ventricular AccELerometer 2
The purpose of the Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2) study is to demonstrate safe and effective operation of the MARVEL 2 features for providing AV synchronous pacing in patients with normal…
- Trial name
- MARVEL2 (NCT03752151)
- Testing
- MARVEL 2 Algorithm Monitor Mode then Adaptive Mode
- Where
- 12 sites in United States, Austria and 6 more
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
Pulmonary Arterial Hypertension
Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH (Zamicastat)
This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease
- Trial name
- NCT04316143
- Testing
- Oral zamicastat
- Where
- 13 sites in Austria, Germany and 5 more
- Volunteers
- 33 people
- Sponsor
- Bial - Portela C S.A.
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
Aortic Valve Stenosis
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic…
- Trial name
- True™Flow (NCT02847546)
- Testing
- True™ Flow Valvuloplasty Perfusion Catheter
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- C. R. Bard
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Acute Myocardial Infarction (AMI), Coronary Occlusion
AngelMed for Early Recognition and Treatment of STEMI
A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.
- Conditions
- Acute Myocardial Infarction (AMI), Coronary Occlusion, Acute Coronary Syndrome
- Trial name
- ALERTS (NCT00781118)
- Testing
- Guardian System
- Where
- 95 sites in United States
- Volunteers
- 1,020 people
- Sponsor
- Angel Medical Systems
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Hungary Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES)
- Trial name
- NCT01892917
- Where
- 13 sites in Hungary
- Volunteers
- 2,000 people
- Sponsor
- Biotronik Hungária Kft.
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
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
Coronary Occlusion
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary…
- Trial name
- NCT03719014
- Testing
- NovaCross
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Nitiloop Ltd.
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Acute Decompensated Heart Failure (ADHF)
Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF
FLOW-HF will assess the impact of intermittent partial occlusion of the SVC and/or IVC, the cardiac filling pressure and the difference of effects between the two occlusion locations (SVC and IVC) using the FlowMod flow…
- Trial name
- FLOW-HF (NCT07810335)
- Testing
- FlowMod System in subjects with acute decompensated heart failure (ADHF)
- Where
- 4 sites in Georgia, Uzbekistan
- Volunteers
- 30 people
- Sponsor
- FlowMod, Inc.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Hypertension Resistant to Conventional Therapy, Bradycardia
Safety and Performance Study of the Moderato System
The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce…
- Conditions
- Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
- Trial name
- NCT02282033
- Testing
- The Moderato System
- Where
- 10 sites in Austria, Chile and 5 more
- Volunteers
- 57 people
- Sponsor
- BackBeat Medical Inc
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW III Asia Registry Orsiro Stent System
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01941290
- Where
- 19 sites in China, India and 3 more
- Volunteers
- 387 people
- Sponsor
- BIOTRONIK Asia Pacific Pte Ltd