Clinical trials: Heart Ventricles
Aortic Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
Bradycardia, Right Ventricular Pacing
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
- Conditions
- Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF)
- Trial name
- LBBAP PMCF (NCT07217392)
- Testing
- LBBAP lead
- Where
- 15 sites in Brazil, France and 7 more
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
- Trial name
- SOLVE-CRT (NCT02922036)
- Testing
- WiSE System
- Where
- 68 sites in United States, Australia and 5 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- EBR Systems, Inc.
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Arrhythmia, Tachycardia
CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen…
- Conditions
- Arrhythmia, Tachycardia, Atrial Fibrillation, Ventricular Fibrillation
- Trial name
- CONNECT (NCT00402246)
- Testing
- Remote Management, In-Office Care
- Where
- 127 sites in United States
- Volunteers
- 2,009 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis, Aortic Valve Disease
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Trial name
- NCT06737757
- Testing
- Artificial polymer heart valves, Bovine pericardial aortic valve
- Volunteers
- 198 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Ventricular Fibrillation, Ventricular Tachycardia
SD01 Registry (SD01 ICD Lead)
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- SD01 Registry (NCT02014675)
- Testing
- SD01 ICD lead
- Where
- 10 sites in Germany
- Volunteers
- 280 people
- Sponsor
- Biotronik SE & Co. KG
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Evaluation of Left Ventricular Autothreshold, Phase Two
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
- Trial name
- ELEVATE 2 (NCT01242722)
- Testing
- CRT-D
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiac Failure
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.
- Conditions
- Heart Failure, Cardiac Failure, Reduced Ventricular Ejection Fraction
- Trial name
- NCT03357731
- Testing
- HNO Donor, Nitroglycerin (NTG)
- Where
- 18 sites in United States, Japan and 2 more
- Volunteers
- 49 people
- Sponsor
- Bristol-Myers Squibb
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Aortic Valve Stenosis
SAPIEN 3 Ultra System PMCF
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
- Trial name
- NCT04555967
- Testing
- SAPIEN 3 Ultra System
- Where
- 11 sites in Austria, Canada and 6 more
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Risk Reduction
Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF
The prevalence of type 2 diabetes mellitus (T2DM) in Qatar and nations worldwide has increased in recent decades into epidemic proportions. Cardiovascular (CVD) disease is the leading cause of death in T2DM patients.
- Trial name
- NCT03794518
- Testing
- Pioglitazone Plus dapaglifliozin
- Where
- Qatar
- Volunteers
- 648 people
- Sponsor
- Hamad Medical Corporation
Ventricular Tachycardia, Cardiovascular Diseases
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in…
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Trial name
- ABCD (NCT00583297)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- CardioDx
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Aortic Valve Disease, Aortic Valve Stenosis
PERCEVAL S Valve Clinical Study for Chinese Registration
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased…
- Trial name
- PERFECT (NCT03481387)
- Testing
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Corcym S.r.l
Aortic Valve Stenosis
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- NCT02209298
- Testing
- CoreValve Transcatheter Valve
- Where
- 25 sites in France, Germany and 2 more
- Volunteers
- 202 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure