Clinical trials: Block, Heart
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
Aortic Valve Stenosis, Aortic Valve Regurgitation
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic
- Trial name
- TAVIS (NCT05536310)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- JenaValve Technology, Inc.
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO)
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting…
- Trial name
- EXPERT CTO (NCT01435031)
- Testing
- CTO Treatment Device
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
The Leaflex™ Brazilian Standalone Study
A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.
- Trial name
- NCT05052684
- Testing
- Leaflex™ Performer
- Where
- Brazil
- Volunteers
- 1 people
- Sponsor
- Pi-cardia
Acute Myocardial Infarction (AMI)
Artificial Intelligence Scalable Solution for ST Myocardial Infarction
The ASSIST clinical study is an observational, multicenter study to assess the performance of a cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, developed to detect Acute Myocardial Infarction…
- Trial name
- ASSIST (NCT06939738)
- Where
- 5 sites in Portugal, Spain
- Volunteers
- 489 people
- Sponsor
- Idoven 1903 S.L.
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Stenosis
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Severe Aortic Stenosis
SOURCE XT REGISTRY
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that…
- Trial name
- NCT01238497
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 104 sites in Austria, Belgium and 16 more
- Volunteers
- 2,954 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Canada Satellite Registry
For the majority of Coronary Artery Disease (CAD), treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedural success.
- Trial name
- NCT01880242
- Where
- 2 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Biotronik Canada Inc
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
Severe Aortic Stenosis
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
- Trial name
- SAFE-TAVI (NCT05492383)
- Testing
- TAVI
- Where
- 6 sites in Spain
- Volunteers
- 119 people
- Sponsor
- Opsens, Inc.
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement…
- Trial name
- NCT05893082
- Testing
- F2 Filter and Delivery System
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- EnCompass Technologies, Inc.
Sick Sinus Syndrome, AV Block
HBP Device EGM Data Collection
This is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent His bundle (HB) pacing lead and an existing Abbott permanent pacemaker, defibrillator, or cardiac…
- Conditions
- Sick Sinus Syndrome, AV Block, Heart Failure
- Trial name
- NCT03564860
- Testing
- Device data collection
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis, Aortic Valve Stenosis
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- HORIZON (NCT02157142)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- HLT Inc.
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
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