Clinical trials: Heart Disease, active
Congenital Heart Disease
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will…
- Trial name
- IMMPACT (NCT03891160)
- Testing
- 3D model of heart
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Columbia University
Structural Heart Disease
NHLBI-Emory Advanced Cardiac CT Reconstruction
Background: Doctors use computed tomography (CT) to get detailed pictures of the heart. CT uses x-rays to gather raw data. Computers assemble this data to make the images doctors look at.
- Trial name
- NCT05372627
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Heart Failure With Reduced Ejection Fraction
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
- Trial name
- RECOVER-HF (NCT06552637)
- Testing
- Synchronized Diaphragmatic Stimulation
- Where
- 5 sites in United States, Georgia
- Volunteers
- 270 people
- Sponsor
- VisCardia Inc.
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
- Trial name
- FIM-TRICSTER (NCT07536724)
- Testing
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Where
- 2 sites in Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medira GmbH
HIV (Human Immunodeficiency Virus), Cardiovascular Diseases (CVD)
Reducing Arterial Inflammation Using Eplerenone and Statins in HIV
HIV has transitioned to a chronic disease in which well-treated persons remain at higher risk for heart disease when compared to the general population.
- Conditions
- HIV (Human Immunodeficiency Virus), Cardiovascular Diseases (CVD), Arterial Inflammation, Heart Disease
- Trial name
- SUNRISE HIV (NCT07892664)
- Testing
- Eplerenone
- Where
- 2 sites in United States
- Volunteers
- 124 people
- Sponsor
- Massachusetts General Hospital
Coronary Artery Disease, Coronary Disease
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized…
- Conditions
- Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
- Trial name
- INTERCLIMA (NCT05027984)
- Testing
- Optical coherence tomography, iFR/FFR/RFR
- Where
- 34 sites in Greece, Italy and 2 more
- Volunteers
- 1,425 people
- Sponsor
- Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Heart Failure, Coronary Heart Disease (CHD)
Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors
Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important.
- Conditions
- Heart Failure, Coronary Heart Disease (CHD), Atrial Fibrillation (AF), Diabetes Mellitus
- Trial name
- NCT06796582
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Technical University of Munich
Kidney Disease, Peritoneal Dialysis (PD)
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
- Conditions
- Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD)
- Trial name
- SCALE-PD (NCT07059962)
- Testing
- Bodyport Cardiac Scale
- Where
- 7 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Bodyport Inc.
Heart Failure, Ischemic Heart Failure
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
The purpose of this clinical study is to evaluate the safety and efficacy of endocardial delivery of HS-001 CS into severe heart failure patients with reduced ejection fraction for 26 weeks after transplantation.
- Conditions
- Heart Failure, Ischemic Heart Failure, Ischemic Heart Disease, Dilated Cardiomyopathy (DCM)
- Trial name
- EMERALD (NCT07347197)
- Testing
- HS-005
- Where
- 5 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Heartseed Inc.
Severe Aortic Valve Stenosis, Valvular Heart Disease
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis.
- Conditions
- Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
- Trial name
- HYSPANIA (NCT07566624)
- Testing
- Hydra THV
- Where
- 5 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación EPIC
Cardiac Disease
Replacing Spatial Filtering With Deep-learning Noise Reduction
Spatial filtering is routinely required to reduce the statistical noise of gated SPECT myocardial perfusion imaging, but at the expense of image blurring.
- Trial name
- DEEPLAIM (NCT07888218)
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Central Hospital, Nancy, France
Cardiac Valve Disease, Coronary Heart Disease
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
The investigators will examine whether the combination of a superficial parasternal block and rectus sheath block with multimodal analgesia can enhance postoperative pain control and reduce opioid administration when compared to…
- Trial name
- NCT07890857
- Testing
- Parasternal and rectus sheath block, ropivacaine 0.25 %
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Hôpital du Valais
Coronary Artery Disease (CAD), Ischemic Heart Disease
Coroflex® ISAR NEO PMCF Study
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device…
- Trial name
- rEPIC07 (NCT05698732)
- Testing
- Coroflex® ISAR NEO coronary stent system
- Where
- 26 sites in France, Spain and 1 more
- Volunteers
- 3,000 people
- Sponsor
- Fundación EPIC
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
EFS of the DUO System for Tricuspid Regurgitation
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- TANDEM II (NCT05913908)
- Testing
- DUO Transcatheter Tricuspid Coaptation Valve System
- Where
- 18 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- CroiValve Limited
Heart Failure
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
The primary research objective is to determine the safety, feasibility, usability and validity of textile-enabled monitoring systems designed to capture physiologic variables, or "biological signals," related to cardiopulmonary…
- Trial name
- NCT05961176
- Testing
- Skiin pediatric band and Skiin biometric pod
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- The Hospital for Sick Children
Atrial Fibrillation, Atrial Flutter
Pericardiotomy in Cardiac Surgery
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Cardiac Events
- Trial name
- PRINCE (NCT06486636)
- Testing
- Left Posterior Pericardiotomy
- Where
- 19 sites in United States, Austria and 3 more
- Volunteers
- 1,400 people
- Sponsor
- Population Health Research Institute
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018.
- Conditions
- Coronary Artery Disease, Arterial Stiffness, Blood Pressure, AORTIC VALVE DISEASES, Mitral Valve Stenosis and/or Insufficiency
- Trial name
- SCAPIS-ReEx (NCT07476703)
- Testing
- Coronary computer tomography (CCTA), Echocardiograhy and aortic ultrasound, Liver elastography
- Where
- Sweden
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Danderyd Hospital
Heart Valve Diseases, Heart Diseases
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical…
- Conditions
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease
- Trial name
- TRIBLAZE (NCT07684313)
- Testing
- Edwards TRIFORMIS RESILIA heart valve
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences