Clinical trials: Heart Ventricles
Transcatheter Aortic Valve Implantation
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months.
- Trial name
- EMPIRE-II (NCT05804903)
- Testing
- (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 7 sites in Finland, Germany and 3 more
- Volunteers
- 177 people
- Sponsor
- NVT GmbH
Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with…
- Trial name
- NCT06320483
- Testing
- Vibroacoustic device BARK VibroLUNG
- Where
- 5 sites in Kazakhstan
- Volunteers
- 310 people
- Sponsor
- Bark Technology LLP
Cardiomyopathies, Heart Diseases
PKP2-ACM Natural History Study
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
- Conditions
- Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Genetic Diseases
- Trial name
- NCT06644742
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 36 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Aortic Valve Stenosis
VitaFlow™ 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™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
PAH
PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
- Trial name
- PAH (NCT03449524)
- Testing
- 75mg CXA-10, 150mg CXA-10
- Where
- 46 sites in United States, United Kingdom
- Volunteers
- 69 people
- Sponsor
- Complexa, Inc.
Conduction Defect
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV…
- Trial name
- STEP IV (NCT05457673)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Heart Failure
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices.
- Trial name
- NCT00187200
- Testing
- Simultaneous VV Pacing, Sequential VV Pacing
- Where
- United States
- Volunteers
- 816 people
- Sponsor
- Abbott Medical Devices
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Aortic Valve Stenosis
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper…
- Trial name
- NCT00820599
- Testing
- Sapien XT™ transcatheter heart valve and delivery system
- Where
- 11 sites in Belgium, France and 2 more
- Volunteers
- 214 people
- Sponsor
- Edwards Lifesciences
Hypertension, Pulmonary, Ventricular Dysfunction, Left
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
- Trial name
- DILATE (NCT01172756)
- Testing
- Riociguat (BAY63-2521)
- Where
- 7 sites in Austria, Czechia and 1 more
- Volunteers
- 39 people
- Sponsor
- Bayer
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
This is a decentralized, single-group, open-label clinical trial evaluating a 12-week regimen of the NeuEve Dryness Treatment Kit (comprising Feminine Moisture Support oral softgels, Bone Support oral capsules, NeuEve Salve…
- Conditions
- Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin), Improves Vaginal Wall Thickness, Reduces Pain During Sex
- Trial name
- NCT07893795
- Testing
- Intervention
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- NeuEve
Moderate Aortic Valve Stenosis
POC for the Treatment of Subjects With Moderate AS Using Valvosoft® Non-Invasive Ultrasound Therapy
This study is a proof of concept looking at the safety of treating subjects with moderate aortic stenosis using a Non-Invasive Ultrasound Therapy.
- Trial name
- NCT06650839
- Testing
- NIUT
- Where
- Serbia
- Sponsor
- Cardiawave SA
Pulmonary Arterial Hypertension
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year.
- Trial name
- REPAIR (NCT02310672)
- Testing
- Macitentan
- Where
- 41 sites in United States, Australia and 10 more
- Volunteers
- 89 people
- Sponsor
- Actelion
Heart Failure With Reduced Ejection Fraction
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated…
- Trial name
- NCT06851949
- Testing
- Vsling
- Where
- 5 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Cardiac Success
Aortic Stenosis
transShield Embolic Protection System Feasibility Study
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT04585308
- Testing
- transShield Embolic Protection System
- Where
- 4 sites in New Zealand, Venezuela
- Volunteers
- 28 people
- Sponsor
- TransAortic Medical, Inc.
Driveline Heart-assisted Device Related Infection
Driveline Silicone Skin Interface Registry
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a…
- Trial name
- SSI (NCT01577433)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Heart Failure
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.
- Trial name
- NCT01917266
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Premature Ventricular Contraction
Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
Arrhythmia is a common disease that may be caused by various cardiovascular diseases. According to statistics, 500,000 people die of severe arrhythmia every year in China, In the United States, approximately 540,000 patients die…
- Trial name
- NCT01235156
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Furui Pharmaceuticals Co., Ltd