Clinical trials: Device Malfunction
End-stage Heart Failure
LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients
Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide.
- Trial name
- AMBU-VAD (NCT04768322)
- Testing
- HeartMate 3 TM Left Ventricular Assist System, Guideline Directed Medical Therapy
- Where
- 8 sites in France
- Volunteers
- 92 people
- Sponsor
- Hospices Civils de Lyon
Chronic Respiratory Failure, Acute Respiratory Failure
Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
Currently, there is no holistic solution for patients with respiratory diseases that includes oxygenation and management of a patient with respiratory disease, combining dynamic and automatic O2 administration and the detection…
- Trial name
- NCT06952816
- Testing
- Emily.AI
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Aether Tech S.L.
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
Heart Failure
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial.
- Trial name
- NCT01609985
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
Developing and Assessing Competencies for Caregivers and Patients With Ventricular Assist Devices
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their…
- Trial name
- NCT00178009
- Testing
- self-paced instruction
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Pittsburgh
Heart Failure
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers.
- Trial name
- CHOICE (NCT00875732)
- Testing
- Bi Ventricular Pacing, Right Ventricular Pacing
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Dundee
Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction
Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring.
- Conditions
- Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Arrythmia, Pacemaker
- Trial name
- IMPLANTED (NCT03061747)
- Testing
- Assesment of outcome of implantable device patients
- Where
- 6 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Right Heart Failure
Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.
- Trial name
- PREVV-RHF-LVAD (NCT05836233)
- Testing
- Pulmonary Vasodilators
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- San Camillo Hospital, Rome
Hypercapnic Respiratory Failure
Novel ECCO2R Device for Hypercapnic Respiratory Failure
The objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful…
- Trial name
- NCT05316532
- Testing
- Prismalung + treatment
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- University of Zurich
Obstructive Sleep Apnea, Heart Failure
Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling
Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced Ejection Fraction (HFrEF) and obstructive sleep…
- Trial name
- MOSAIC (NCT02948894)
- Testing
- Mandibular advancement device
- Where
- 2 sites in Singapore
- Volunteers
- 100 people
- Sponsor
- National University of Singapore
Thrombosis, Blood Coagulation Disorder
Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)
Consenting patients with end-stage heart failure that are implanted with/candidates for implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane…
- Conditions
- Thrombosis, Blood Coagulation Disorder, Platelet Thrombus, Platelet Dysfunction Due to Aspirin
- Trial name
- PASVAD (NCT03255928)
- Testing
- PAS assay, TGT
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
Chronic Myocardial Ischemia
Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support.
- Trial name
- MESAD (NCT02460770)
- Testing
- Autologous mesenchymal stem cells
- Where
- France
- Sponsor
- University Hospital, Toulouse
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)
Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure.
- Trial name
- NCT01446796
- Testing
- Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Duke University
Heart Failure
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent…
- Trial name
- BeneMACs (NCT00983190)
- Testing
- Left Ventricular Assist Device (HeartMate II)
- Where
- 2 sites in Belgium
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Deutsches Device Qualitätsregister
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.
- Trial name
- NCT01173783
- Where
- 7 sites in Germany
- Volunteers
- 4,008 people
- Sponsor
- Stiftung Institut fuer Herzinfarktforschung
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Heart Failure, Arrhythmia
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
[Plain language]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death…
- Conditions
- Heart Failure, Arrhythmia, Decompensated Heart Failure, Atrial Fibrillation
- Trial name
- NCT06989580
- Testing
- BIOMONITOR IV with study software
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 300 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Pilot Study of the QI Device for Monitoring of Patients With Congestive Heart Failure
The present study proposes to utilize a novel, wearable device, QI Device, which has multiple sensors embedded in a "wrist-watch" in order to explore its monitoring capabilities in individuals with congestive heart failure.
- Trial name
- NCT02343523
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Scripps Translational Science Institute
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices