Clinical trials: Device Malfunction, open to volunteers
Advanced Heart Failure
First in Human Study of the Icoms Flowmaker
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump…
- Trial name
- FAIR (NCT07632586)
- Testing
- Cardiac assist device implantation during surgical intervention
- Where
- 2 sites in Czechia, France
- Volunteers
- 10 people
- Sponsor
- FineHeart
Decompensated Chronic Heart Failure
Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable…
- Trial name
- NCT07350759
- Testing
- wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- CHFDX,Inc.
Heart Failure
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
- Trial name
- AFR Registry (NCT04405583)
- Testing
- Occlutech Atrial Flow Regulator
- Where
- 36 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Occlutech International AB
Diabetes Mellitus, Coronary Arterial Disease (CAD)
Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus
Purpose of this study: The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own.
- Conditions
- Diabetes Mellitus, Coronary Arterial Disease (CAD), de Novo Coronary Lesions, De Novo Stenosis
- Trial name
- DUBSTENT-DM (NCT07303439)
- Testing
- Percutaneous Coronary Intervention
- Where
- Ireland
- Volunteers
- 120 people
- Sponsor
- Royal College of Surgeons, Ireland
Renal Insufficiency, Chronic, Kidney Failure, Chronic
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis).
- Conditions
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Chronic Kidney Diseases
- Trial name
- CORDIAL (NCT06314503)
- Testing
- WEAKID
- Where
- 3 sites in Italy, Netherlands and 1 more
- Volunteers
- 12 people
- Sponsor
- UMC Utrecht
Heart Failure With Reduced Ejection Fraction (HFrEF)
Correlation of Typical LBBB Mechanical Activation Pattern by 2D Strain Echocardiography With Acute GWE Improvement in Patients Receiving LBBp or Conventional BiVp for Cardiac Resynchronization Therapy (Echo LBBp)
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy.
- Trial name
- ECHO-LBBp (NCT06689111)
- Testing
- Left bundle branch pacing lead, CRT with the standard method through cs
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University Hospital of Patras
Healthy, Respiratory Disease
A New Portable Device for Non-invasive Ventilatory Support
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes.
- Trial name
- PREVENT (NCT06716502)
- Testing
- Portable CPAP efficacy, Portable CPAP usability assessment
- Where
- 3 sites in Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Università Vita-Salute San Raffaele
Atrial Fibrillation (AF), Heart Failure
A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study
This is a prospective study validating a new machine-learning algorithm that detects atrial fibrillation (AF) from photoplethysmography (PPG) signals, developed for integration into the Seerlinq remote monitoring platform.
- Trial name
- HeartCore AF (NCT07749183)
- Testing
- PPG-based AF detection algorithm
- Where
- Slovakia
- Volunteers
- 200 people
- Sponsor
- Seerlinq s. r. o.
Cardiac Pacemaker Malfunction, ICD Malfunction
Perioperative Management Evaluation in Patients With CIED
Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.
- Conditions
- Cardiac Pacemaker Malfunction, ICD Malfunction, Cardiac Pacemaker Electrical Interference, Anesthesia Complication
- Trial name
- EVINCE (NCT04331249)
- Testing
- surgery or catheter based cardiac procedure (catheter ablation)
- Where
- 2 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Klinikum-Fuerth
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Tricuspid Regurgitation, Right Heart Failure
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients.
- Conditions
- Tricuspid Regurgitation, Right Heart Failure, Cardiac Remodeling, Ventricular, Cardiac Remodeling, Atrial
- Trial name
- NCT05179616
- Testing
- Transcatheter edge-to-edge tricuspid valve repair
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios Klinikum Pforzheim
Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and…
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block, Second and Third Degree, Heart Failure
- Trial name
- CIED-CARE (NCT06652750)
- Testing
- Routine Management, 5G Cloud Follow-up
- Where
- 2 sites in China
- Volunteers
- 688 people
- Sponsor
- The Third People's Hospital of Chengdu
Heart Failure
Wearable Technology in Heart Failure Patients
The primary objective is to establish a Cleveland Clinic-led registry designed to integrate continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University (CWRU)-based…
- Trial name
- Wearables-HF (NCT07650669)
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- The Cleveland Clinic
Heart Failure, Gut Microbiome
Enhanced Nutritional Optimization in LVAD Trial
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut…
- Conditions
- Heart Failure, Gut Microbiome, Nutritional Deficiency
- Trial name
- ENOL (NCT05655910)
- Testing
- Ensure Surgery Immunonutrition shake
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Acute Pancreatitis, Organ Failure, Multiple
Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis
This is a single-centre, randomised-controlled, open-label, feasibility study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA…
- Trial name
- NUC-SAP1 (NCT06566638)
- Testing
- NucleoCapture device
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Liverpool University Hospitals NHS Foundation Trust
Heart Failure, Univentricular Heart
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks…
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases
- Trial name
- RegiVe (NCT04782232)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Berlin Heart GmbH
Heart Failure
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries.
- Trial name
- BRITISH (NCT05568069)
- Testing
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Where
- 47 sites in United Kingdom
- Volunteers
- 2,504 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Atrial Fibrillation (AF), Heart Failure and Reduced Ejection Fraction
Wearable Device-Assisted Remote Management to Improve Prognosis in Patients With Acute Heart Failure Complicated by Atrial Fibrillation: WARM-HF Trial (Stage 2)
With the advancement of wearable technology, continuous non-invasive monitoring of vital signs, arrhythmia burden, and physical status has become increasingly feasible.
- Trial name
- NCT07687862
- Testing
- wearable device based remote management (GDMT titration for HF, rhythm control and anticoagulation management for AF)
- Volunteers
- 818 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Stenosis, Cerebral Arterial Diseases
Wearable Devices Assist in the Detection, Screening, and Management of Major Diseases in Middle-aged and Elderly Populations
The goal of this randomized controlled trial is to evaluate the effectiveness of wearable devices (Huawei smartwatches) in aiding the detection, and screening of major diseases (e.g., coronary artery disease, hypertension) in…
- Conditions
- Coronary Stenosis, Cerebral Arterial Diseases, Hypertension, Parkinson Disease
- Trial name
- NCT06980064
- Testing
- Smartwatch + GP, GP only
- Volunteers
- 800 people
- Sponsor
- Tongji Hospital
Advanced Heart Failure, Mechanical Circulatory Support
Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support
Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL).
- Conditions
- Advanced Heart Failure, Mechanical Circulatory Support, Left Ventricular Assist Device, Palliative Care
- Trial name
- PALL-VAD (NCT07445932)
- Testing
- Palliative care intervention
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Medstar Health Research Institute