Clinical trials: Cardiac Function, open to volunteers
Tricuspid Regurgitation Functional
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who…
- Trial name
- Pivot TR (NCT07385625)
- Testing
- Pivot Bridge
- Where
- 4 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Bradycardia, Remote Monitoring
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
- Trial name
- CALLIOPE (NCT05165095)
- Testing
- Pacemaker implantation
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- MicroPort CRM
Atrial Fibrillation (AF)
Blood Pressure Monitor (TH-75) Atrial Fibrillation Detection Function Clinical Trial
This study evaluates the accuracy of a blood pressure monitor in detecting atrial fibrillation by comparing its results with a standard diagnostic method.
- Trial name
- NCT07442175
- Where
- China
- Volunteers
- 392 people
- Sponsor
- Andon Health Co., Ltd
Heart Failure
A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure.
- Trial name
- 8282-Reduced (NCT06979375)
- Testing
- CDR132L
- Where
- 92 sites in Australia, Czechia and 8 more
- Volunteers
- 200 people
- Sponsor
- Novo Nordisk A/S
Hemodynamic Monitoring
Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects.
- Trial name
- NCT07862608
- Testing
- Noninvasive Hemodynamic Monitoring System
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- AcQumen Medical, Inc.
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
Tricuspid Insufficiency, Tricuspid Regurgitation (TR)
PASCAL Precision-GDMT Registry
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be…
- Conditions
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction
- Trial name
- PASCAL (NCT07578129)
- Volunteers
- 50 people
- Sponsor
- Ceric Sàrl
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (FR)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (FR) (NCT07757607)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Hemodynamic Monitoring
UltraTrac Clinical Pilot Study
This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac…
- Trial name
- ULTRA-CO (NCT07864714)
- Testing
- Noninvasive Hemodynamic Monitoring System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AcQumen Medical, Inc.
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (DE)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (DE) (NCT07757776)
- Testing
- Transcatheter mitral valve repair (MRace Implant and Delivery System)
- Volunteers
- 20 people
- Sponsor
- Polares Medical SA
Rapid Arrhythmia, Atrial Fibrillation (AF)
Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Conditions
- Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT)
- Trial name
- NCT07032948
- Testing
- FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
- Volunteers
- 300 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Mitral Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular Inc.
Functional Mitral Regurgitation, Mitral Regurgitation
The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
This is a retrospective and prospective, multi-center, post-market observational registry study. The primary objective of this post market registry is to continue to evaluate the long term safety and performance of the Carillon®…
- Trial name
- CINCH-FMR (NCT05677568)
- Testing
- Carillon Mitral Contour System
- Where
- 19 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Cardiac Dimensions, Inc.
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Study to evaluate the safety and performance of the INNOVALVE system
- Trial name
- TWIST-EFS (NCT04919980)
- Testing
- INNOVALVE system
- Where
- 21 sites in United States
- Volunteers
- 85 people
- Sponsor
- Edwards Lifesciences
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD).
- Trial name
- NCT07850063
- Testing
- Survodutide
- Where
- 34 sites in United States, China and 3 more
- Volunteers
- 600 people
- Sponsor
- Boehringer Ingelheim
Glomerular Filtration Rate, Heart Failure
MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure
The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance…
- Trial name
- NCT07349797
- Testing
- Lumitrace, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR), Iohexol
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- MediBeacon
Ventricular Dysfunction, Left, Ventricular Function, Left
Federated Learning for Point-of-Care Cardiac Ultrasound
This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations.
- Conditions
- Ventricular Dysfunction, Left, Ventricular Function, Left, Echocardiography, Ultrasonography
- Trial name
- FL-POCUS (NCT07800962)
- Testing
- Focused Cardiac Point-of-Care Ultrasonography, FL-POCUS Federated Machine-Learning Analysis System
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Truway Health, Inc.