Clinical trials: Heart Ventricles
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.
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Trial name
- NCT04414865
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
Ischemic Heart Failure
PARACHUTE China Approval Trial
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system.
- Trial name
- NCT02240940
- Testing
- Parachute Implant
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- CardioKinetix, Inc
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Heart Failure, Dilated Cardiomyopathy
A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with…
- Trial name
- AUGMENT-HF (NCT01311791)
- Testing
- Algisyl-LVR, Standard medical therapy
- Where
- 18 sites in Australia, Germany and 4 more
- Volunteers
- 78 people
- Sponsor
- LoneStar Heart, Inc.
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis, Severe
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic…
- Trial name
- NCT05989074
- Testing
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- Volunteers
- 130 people
- Sponsor
- Ceric Sàrl
Heart Failure
PORTHOS - PORTuguese Heart Failure Observational Study
This study aims to determine the prevalence of heart failure in the resident population in mainland Portugal aged 50 years or above, using a contemporary, guideline-based diagnostic approach, to optimize patient management and…
- Trial name
- PORTHOS (NCT05434923)
- Where
- 13 sites in Portugal
- Volunteers
- 6,189 people
- Sponsor
- AstraZeneca
High-risk PCI
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd.
- Trial name
- NCT07622446
- Testing
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Dynaheart Medtech Co., Ltd.
Stenoses, Aortic Valve
REPRISE China - Clinical Evaluation in China
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high…
- Trial name
- NCT03084510
- Testing
- Lotus Edge™ Valve System
- Where
- China
- Sponsor
- Boston Scientific Corporation
Cardiac Function in Young Athletes
Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury
Young athletes are usually regarded as a special subgroup of healthy individuals with a unique lifestyle who are apparently invulnerable and often capable of extraordinary physical achievement.
- Trial name
- Enduoxy (NCT02207101)
- Testing
- E-OJ-01 (OXYJUN)
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Aortic Valve Stenosis, Severe Aortic Stenosis
A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native…
- Trial name
- CREATE (NCT07734025)
- Testing
- Investigational Transcatheter Aortic Valve Replacement System
- Volunteers
- 30 people
- Sponsor
- Onecrea Medical Inc.
Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction
A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure
This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Ischemic and Non-ischemic Cardiomyopathy
- Trial name
- NCT07795359
- Testing
- Subcutaneous cardiac microcurrent treatment
- Volunteers
- 60 people
- Sponsor
- Berlin Heals GmbH
Heart Failure With Reduced Ejection Fraction, HFrEF
VisONE Heart Failure Study: Pilot
The VisONE HF pilot is a feasibility pilot for evaluating the benefits and risks of chronically delivering Asymptomatic Diaphragmatic Stimulation in medical refractory heart failure patients using the VisONE™ implantable system…
- Trial name
- NCT03484780
- Testing
- VisONE ADS
- Where
- 3 sites in Georgia, Ukraine
- Volunteers
- 15 people
- Sponsor
- VisCardia Inc.
Aortic Valve Stenosis
Hydra Registry - UK
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the…
- Trial name
- NCT06507579
- Testing
- Hydra transcatheter aortic valve (THV) series
- Where
- 4 sites in United Kingdom
- Volunteers
- 250 people
- Sponsor
- Sahajanand Medical Technologies Limited
Severe Aortic Stenosis
CoreValve Advance International Post Market Study
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
- Trial name
- NCT01074658
- Testing
- Medtronic CoreValve System
- Where
- 44 sites in Belgium, Colombia and 10 more
- Volunteers
- 1,015 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
Arrhythmias
Non Invasive Arrhythmia Detection in Hospital Settings
This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.
- Trial name
- EVE (NCT00919087)
- Testing
- Avivo System
- Volunteers
- 25 people
- Sponsor
- Corventis, Inc.