Clinical trials: Device Malfunction
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Intrauterine Device Complications, Contraceptive Device Failure
Patient Factors Associated With Fragmentation of Copper Intrauterine Device (IUD) Requiring Hysteroscopic Removal
The purpose of this retrospective chart review was to identify risks factors for patients associated to Cooper IUD fragmentation upon removal resulting in the requirement of a hysteroscopy evaluation.
- Conditions
- Intrauterine Device Complications, Contraceptive Device Failure, IUD Fragmentation, Retained Intrauterine Device
- Trial name
- NCT07351084
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of Kansas Medical Center
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Systolic Heart Failure
Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support
Medamacs is a prospective, observational study of ambulatory patients with advanced heart failure. The study enrolls patients who have not yet received a Left Ventricular Assist Device (LVAD) but who receive their care at a…
- Trial name
- Medamacs (NCT01932294)
- Where
- 11 sites in United States
- Volunteers
- 171 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Chronic Heart Failure, Patients That Have Received a Left Ventricular Assist Device
Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients With Chronic Heart Failure
The aim of the study is to determine the safety and feasibility of giving an adeno-associated viral vector expressing the sarcoplasmic reticulum calcium ATPase (SERCA2a), driven by the CMV promoter (AAV1-CMV-SERCA2a), to heart…
- Trial name
- SERCA-LVAD (NCT00534703)
- Testing
- AAV1/SERCA2a
- Where
- 2 sites in United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Heart Failure, Gastrointestinal Bleeding
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices.
- Trial name
- NCT03784963
- Testing
- Omega 3 fatty acids
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Acute Kidney Injury
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute kidney injury (AKI).
- Trial name
- NCT01400893
- Testing
- SCD
- Where
- 26 sites in United States
- Volunteers
- 134 people
- Sponsor
- SeaStar Medical
Heart Failure, Cardiomyopathy
The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe.
- Conditions
- Heart Failure, Cardiomyopathy, Ventricular Dysfunction
- Trial name
- NCT01442129
- Testing
- MPC Intramyocardial injection, Control Solution
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Deborah Ascheim
Acute Respiratory Distress Syndrome, Shock
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.
- Conditions
- Acute Respiratory Distress Syndrome, Shock, Ventilatory Failure, Cardiogenic Pulmonary Edema
- Trial name
- NCT01680783
- Testing
- Non invasive ventilation using a helmet hyperbaric device, Noninvasive ventilation via facemask
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- University of Chicago
Heart Failure
C-Pulse® System: A Heart Assist Device Clinical Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
- Trial name
- COUNTER-HF (NCT01740596)
- Testing
- C-Pulse® System Counterpulsation
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Nuwellis, Inc.
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Chronic Heart Failure
A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management.
- Trial name
- DT2 (NCT01966458)
- Testing
- HeartWare® VAS (HVAD), Control LVAD
- Where
- 47 sites in United States
- Volunteers
- 494 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Heart Failure With Reduced Ejection Fraction
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary…
- Trial name
- OUTSTEP-HF (NCT02900378)
- Testing
- LCZ696 (Sacubitril/Valsartan), Enalapril
- Where
- 119 sites in Belgium, Bulgaria and 17 more
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Device Malfunction, ICD
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular…
- Conditions
- Device Malfunction, ICD, Pacemaker Lead Dysfunction
- Trial name
- ISEE (NCT04055740)
- Testing
- IVUS Imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Chicago
Sick Sinus Syndrome, Complete Heart Block
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or…
- Conditions
- Sick Sinus Syndrome, Complete Heart Block, Syncope, Chronic Systolic Heart Failure
- Trial name
- ENVELOPE (NCT02809131)
- Testing
- polymixin/bacitracin, cephalexin, or levofloxacin, or clindamycin, Saline
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Vanderbilt University Medical Center
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
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.
- Trial name
- NCT02548455
- Testing
- Quartet 1457Q LV Lead
- Where
- 30 sites in United States
- Volunteers
- 499 people
- Sponsor
- Abbott Medical Devices
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
T-cell Depleted Alternative Donor Transplantation
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00968864
- Testing
- CliniMACS® (T cell depletion)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Wake Forest University Health Sciences
Heart Failure
C-Pulse IDE Feasibility Study- A Heart Assist System
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better…
- Trial name
- NCT00815880
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Nuwellis, Inc.
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices